Category Archives: devices

FDA Publish Guidance on Processing/Reprocessing Medical Devices in Health Care Settings

Posted on June 6, 2011 by admin| Leave a comment

FDA Publish Guidance on Processing/Reprocessing Medical Devices in Health Care Settings

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When final, this guidance will supersede Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance. This draft guidance document updates and clarifies the recommended content of, and review procedures for, premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, and investigational device exemptions applications (IDE), concerning the labeling instructions for reprocessing reusable medical devices. In addition, this draft document provides more detail about FDA’s recommendations for the validation of processes intended to support reprocessing.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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NICE Publish Guidance on Endovascular Stent-Grafting of Popliteal Aneurysms

Posted on May 30, 2011 by admin| Leave a comment

NICE Publish Guidance on Endovascular Stent-Grafting of Popliteal Aneurysms

Current evidence on endovascular stent-grafting of popliteal aneurysms is limited in quantity but shows no major safety concerns. Evidence on efficacy is inadequate because it is limited to the short-term. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

Clinicians wishing to undertake endovascular stent-grafting of popliteal aneurysms should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients and their carers understand the uncertainty about the procedure’s long-term efficacy and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/guidance/IPG390/publicinfo).
• Audit and review clinical outcomes of all patients having endovascular stent-grafting of popliteal aneurysms (see section 3.1).

Patient selection for this procedure should be carried out by a multidisciplinary team which should include a vascular surgeon and an interventional radiologist with specific training and experience in the technique.

NICE encourages research into endovascular stentgrafting of popliteal aneurysms and may review this procedure on publication of further evidence.

For Assistance with Submitting Evidence to NICE Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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NICE Publish Guidance on Carotid Artery Stent Placement in Extracranial Carotid Stenosis

Posted on May 29, 2011 by admin| Leave a comment

NICE Publish Guidance on Carotid Artery Stent Placement in Extracranial Carotid Stenosis

Current evidence on the safety and efficacy of carotid artery stent placement for symptomatic extracranial carotid stenosis is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance and audit or research.

During the consent process, clinicians should ensure that patients understand the risk of stroke and other complications associated with this procedure. Clinicians should also ensure that patients understand the reasons for advising carotid artery stent placement rather than endarterectomy in their particular case.

Patient selection should be carried out by a multidisciplinary team, which should include an interventional radiologist or a neuroradiologist, a vascular surgeon and a physician with a specialist interest in stroke.

This procedure should only be carried out by clinicians with specific training and expertise in the technique who regularly perform complex endovascular interventions. The Royal College of Radiologists has produced training standards.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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NICE publish Guidance on Carotid Artery Stent Placement

Posted on May 28, 2011 by admin| Leave a comment

NICE publish Guidance on Carotid Artery Stent Placement

Current evidence on the safety of carotid artery stent placement for asymptomatic extracranial carotid stenosis shows well-documented risks, in particular the risk of stroke. The evidence on efficacy is inadequate in quantity. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research. Clinicians wishing to undertake carotid artery stent placement for asymptomatic extracranial carotid stenosis should take the following actions.

• Ensure that patients and their carers understand the uncertainty about the procedure’s efficacy, the risk of stroke and other complications, and the reasons for advising stenting rather than endarterectomy or best medical treatment alone in their particular case. Patients should be provided with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/guidance/IPG388/publicinfo)

Patient selection should be carried out by a multidisciplinary team, which should include an interventional radiologist or a neuroradiologist, a vascular surgeon and a physician with specialist interest in stroke. Cardiac surgeons and cardiologists should liaise with the multidisciplinary team in relation to patients being considered for this procedure as a prelude to cardiac surgery. This procedure should only be carried out by clinicians with specific training and expertise in the technique who regularly perform complex endovascular interventions. The Royal College of Radiologists has produced training standards.

NICE encourages clinicians either to enter patients into the ACST-2 trial (Asymptomatic Carotid Artery Surgery Trial 2; www.nds.ox.ac.uk/acst) or to submit data to the Endovascular Carotid Register, run by the British Society of Interventional Radiology and the Vascular Society of Great Britain and Ireland (www.bsir.org and www.vascularsociety.org.uk). NICE may review this procedure on publication of further evidence.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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NICE Publish Guidance on Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Failure

Posted on May 26, 2011 by admin| Leave a comment

NICE Publish Guidance on Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Failure

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Evidence on the safety of extracorporeal membrane oxygenation (ECMO) for severe acute respiratory failure in adults is adequate but shows that there is a risk of serious side effects. Evidence on its efficacy is inadequate to draw firm conclusions: data from the recent CESAR (Conventional ventilation or extracorporeal membrane oxygenation for severe adult respiratory failure) trial were difficult to interpret because different management strategies were applied among many different hospitals in the control group and a single centre was used for the ECMO treatment group. Therefore this procedure should only be used with special arrangements for clinical governance, consent and research.

Clinicians wishing to undertake ECMO for severe acute respiratory failure in adults should take the following actions.
• Inform the clinical governance leads in their Trusts.
• Whenever possible, ensure that patients and their carers understand the uncertainty about the procedure’s efficacy and its risks and provide them with clear written information. In
addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/guidance/IPG391/publicinfo).

Extracorporeal membrane oxygenation for severe acute respiratory failure in adults should only be carried out by clinical teams with specific training and expertise in the procedure.

Clinicians are encouraged to submit data on all adults undergoing ECMO for severe acute respiratory failure to the international Extracorporeal Life Support Organization register (www.elso.med.umich.edu).

NICE encourages further research into the use of innovative technologies for the management of severe acute respiratory failure, and may review this guidance on publication of further evidence.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA and FDA Accounts Parallel Assessment of Quality by Design Applications

Posted on May 25, 2011 by admin| Leave a comment

EMA and FDA Accounts Parallel Assessment of Quality by Design Applications

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The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are launching a three-year pilot program that will allow parallel evaluation of relevant quality data components, known as Quality by Design (QbD), of selected applications that are submitted to both agencies at the same time. The pilot will be starting on 1 April 2011.

QbD in pharmaceuticals involves an enhanced systematic and science-based approach to development and manufacturing, to better ensure product quality. Several guidelines and question-and-answer documents have been developed by the International Conference on Harmonisation (ICH) in order to facilitate the implementation of QbD. Taking into account the global perspective of pharmaceutical manufacturing, and to facilitate the harmonised implementation of the ICH concepts, the EMA and FDA agreed that experts from both agencies should exchange their views using real applications.

Under this program, both agencies will assess the parts of the applications relevant to QbD, such as development, design space and real-time release testing. The evaluation will be performed separately by each agency, with regular communication and consultation throughout the review, with the aim of having a common list of questions to the applicants and a harmonised evaluation of their responses.

In Europe this pilot applies to new marketing authorisation applications and quality-related scientific advice requests. Type II variations may be included on a case-by-case basis. In the US the programme will cover new drug marketing applications (NDA), prior-approval supplements (sNDA) and chemistry manufacturing control meeting requests. The pilot program will only include chemical entities. However, ongoing consideration will be given to other areas of collaboration.

Participation in the pilot is voluntary, and interested applicants/sponsors are asked to notify both agencies three months prior to submission of an application. The notification should include a brief description of the QbD elements in the application and expected submission dates. This pilot will conclude on 31 March 2014. Both agencies will jointly assess and publish the outcome of this pilot programme

EMA and FDA Accounts Parallel Assessment of Quality by Design Applications

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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FDA Publish Guidance, How to Write a Request for Designation

Posted on April 27, 2011 by admin| Leave a comment

FDA Publish Guidance, How to Write a Request for Designation

This guidance is intended to clarify the type of information the Office of Combination Products (OCP) recommends that a sponsor include in a Request for Designation (RFD). The goal of this guidance is to help a sponsor understand the type of information FDA needs to determine the regulatory identity or classification of a product as a drug, device, biological product, or combination product,1 and to assign the product to the appropriate Agency component for review and regulation. This guidance addresses 21 CFR Part 3, as amended by the final rule defining the primary mode of action (PMOA) of a combination product (PMOA Final Rule). FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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MHRA Publish Guidance on Clinical Trials for Devices

Posted on March 21, 2011 by admin| Leave a comment

MHRA Publish Guidance on Clinical Trials for Devices

These Notes outline the legal requirements relating to the conduct and performance of a clinical investigation as set out in these Regulations. They also provide background and guidance to manufacturers on how to apply for pre-clinical assessment of a proposed clinical investigation in human subjects, involving a device falling within the scope of the Regulations.

Manufacturers wishing to make an application for pre-clinical assessment of a proposed clinical investigation of an active implantable medical device or a medical device to be carried out in part or in whole in the UK should apply to the Medicines & Healthcare products Regulatory Agency of the Department of Health (referred to in this document as the UK Competent Authority), in accordance with these Guidance Notes.

This guidance is intended as a general explanation of the legislation and should not be regarded as an authoritative statement of the law nor as having any legal consequence. It follows that manufacturers and others should not rely solely on this guidance but should consult the legislation referred to and make their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions or other statements in the guidance whether negligent or otherwise. An authoritative statement could
be given only by the courts. Information and assistance in individual cases may be sought from the UK Competent Authority whose address and telephone number are given on pages 12 – 13 of this document.

For Assistance with the development of a medical device Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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DOH Has Short Guide on Certificate of Free Sale Appliation System Available

Posted on February 10, 2011 by admin| Leave a comment

DOH Has Short Guide on Certificate of Free Sale Application System Available.

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This is a short guide on how to register and place applications on the system.

For Assistance with Applying for a Certificate of Free Sale or Medical Device Registration Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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MHRA Publishes Draft for Comment: Joint Relpacement Vigilance Systems

Posted on January 28, 2011 by admin| Leave a comment

MHRA Publishes Draft for Comment: Joint Relpacement Vigilance Systems

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This guidance document gives advice to manufacturers on the notification of adverse incidents involving joint replacement implants under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC and Directive 2005/05/EC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System and the Medicines and Healthcare products Regulatory Agency’s Directives Bulletin 3 ‘Guidance on the operation of the EU vigilance system in the UK’. This guidance sets out the Medicines and Healthcare products Regulatory Agency’s (MHRA) views on the interpretation of the Medical Devices Regulations. It should not be considered to be an authoritative statement of the law in any particular case as it is intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

For Assistance with Pharamcovigilance Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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MHRA Publish Guidance for Manufactures on Clinical Investigations in the UK

Posted on January 27, 2011 by admin| Leave a comment

MHRA Publish Guidance for Manufactures on Clinical Investigations in the UK

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These Notes outline the legal requirements relating to the conduct and performance of a clinical investigation as set out in these Regulations. They also provide background and guidance to manufacturers on how to apply for pre-clinical assessment of a proposed clinical investigation in human subjects, involving a device falling within the scope of the Regulations.

Manufacturers wishing to make an application for pre-clinical assessment of a proposed clinical investigation of an active implantable medical device or a medical device to be carried out in part or in whole in the UK should apply to the Medicines & Healthcare products Regulatory Agency of the Department of Health (referred to in this document as the UK  Competent Authority), in accordance with these Guidance Notes.

This guidance is intended as a general explanation of the legislation and should not be regarded as an authoritative statement of the law nor as having any legal consequence. It follows that manufacturers and others should not rely solely on this guidance but should consult the legislation referred to and make their own decisions on matters affecting them in
conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

For Assistance with Planning and Implementing a Clinical Trial Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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MHRA Publishes Draft Guidance on Vigilance Systems for Joint Implants

Posted on January 21, 2011 by admin| Leave a comment

MHRA Publishes Draft Guidance on Vigilance Systems for Joint Implants.

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This guidance document gives advice to manufacturers on the notification of adverse incidents involving joint replacement implants under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC and Directive 2005/05/EC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System and the Medicines and Healthcare products Regulatory Agency’s Directives Bulletin 3 ‘Guidance on the operation of the EU vigilance system in the UK’ . This guidance sets out the Medicines and Healthcare products Regulatory Agency’s (MHRA) views on the interpretation of the Medical Devices Regulations . It should not be considered to be an authoritative statement of the law in any particular case as it is intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

For Assistance with the Development of Medical Devices Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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FDA Publish Guidance on Blood Lancet Labeling

Posted on December 9, 2010 by admin| Leave a comment

FDA Publish Guidance on Blood Lancet Labeling

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This guidance recommends changes in the labeling of blood lancet (e.g., fingerstick) devices (21 CFR 878.4800) (included under manual surgical instruments for general use). FDA is concerned about the risk of transmission of hepatitis and other bloodborne pathogens when blood lancets are used to obtain blood from more than one patient. FDA is recommending that all blood lancets designed to be used more than once (for example, when a blade attached to a reusable base device is changed) be labeled for use only on a single patient obtaining personal blood samples. Manufacturers of blood lancets should clearly state in their labeling that blood lancets are intended only for single use or, in the case of lancet devices designed to be used more than once, for multiple uses in only a single patient.

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FDA Publish Guidance on Performance of Clostridium Difficile Diagnostics

Posted on December 1, 2010 by admin| Leave a comment

FDA Publish Guidance on Performance of Clostridium Difficile Diagnostics

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FDA is issuing this draft guidance to provide industry and agency staff with updated recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs) intended to be used for detecting Clostridium difficile (C. difficile). The document is a revision of “Review Criteria for Assessment of Laboratory Tests Directed at Assisting in the Diagnosis of C. difficile Associated Disease” issued on May 31, 1990. It is updated to include new issues and technologies identified since the 1990 guidance. Such methods include detection of C. difficile nucleic acids (e.g., C. difficile toxin B gene by nucleic acid amplification (NAAT) methods such as the Real-Time Polymerase Chain Reaction (RT-PCR) technique).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Draft Recommendations on Dossiers for Combination Products

Posted on November 24, 2010 by admin| Leave a comment

EMA Publish Draft Recommendations on Dossiers for Combination Products.

This recommendation aims to provide interested parties with appropriate guidance on procedural aspects as well as format and data requirements to facilitate the consultation procedure to the European Medicines Agency by notified bodies on:
• Medicinal products within the meaning of Article 1 of Directive 2001/83/EC incorporated, as an integral part in a medical device and which are liable to act upon the body with action ancillary to that of the device.
•Medicinal product constituents or medicinal products derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC incorporated, as an integral part in a medical device and which are liable to act upon the human body with action ancillary to that of the device.
These substances are referred to hereinafter respectively as ancillary medicinal substances and as ancillary human blood derivatives.
This recommendation applies to any application for consultation submitted to the European Medicines Agency by notified bodies.

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FDA Workshop – Innovations In Diabetes, Artifical Pancrease

Posted on November 9, 2010 by admin| Leave a comment

FDA Workshop – Innovations In Diabetes, Artificial Pancreas

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 The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are announcing a public workshop entitled ``Innovations in Technology for the Treatment of Diabetes: Clinical Development of
the Artificial Pancreas (an Autonomous System).'' The topics to be discussed are the current state of device systems for autonomous systems for the treatment of diabetes mellitus, the challenges in
developing this expert system using existing technology, a discussion of the clinical expectations and success criteria for these systems, and a discussion of development plans for the transition of this device
system toward an outpatient setting.    Date and Time: The public workshop will be held on November 10, 2010, from 8 a.m. to 5 p.m. Persons interested in attending this meeting must register by 5 p.m. on November 3, 2010.  Location: The meeting will be held at the Hilton Washington, DC North/Gaithersburg Hotel, 620 Perry Pkwy., Gaithersburg, MD 20877.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA Publish Guidance on Humanitarian Device Exemptions (HDE)

Posted on October 28, 2010 by admin| Leave a comment

FDA Publish Guidance on Humanitarian Device Exemptions (HDE)

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This guidance document answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for Humanitarian Device Exemption (HDE) authorized by section 510(m)(2) of the Federal Food, Drug, and Cosmetic Act (the Act). This guidance document reflects the additional requirements set forth in the Pediatric Medical Device Safety and Improvement Act of 2007.
For the purposes of this guidance, “you” refers to the HDE holder, the Institutional Review Board (IRB), or the clinical investigator depending upon how the question is asked and “we” refers to FDA.

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FDA Draft Guidance on, Herpes Simplex Virus, Types 1 and 2 Serological Assays

Posted on October 15, 2010 by admin| Leave a comment

FDA Draft Guidance on, Herpes Simplex Virus, Types 1 and 2 Serological Assays

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This special controls guidance document was developed to support the reclassification of the herpes simplex virus types 1 and 21 (HSV 1 and 2) serological assays into class II. HSV serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.
This document does not address HSV nucleic acid amplification assays. Please contact the Division of Microbiology Devices in the Office of In Vitro Diagnostic Device Evaluation and Safety for further information on HSV 1 and/or 2 nucleic acid amplification assay submissions.
This guidance is issued in conjunction with a Federal Register final rule announcing the reclassification of HSV 1 and 2 serological assays from class III into class II and codifying the classification at 21 CFR 866.3305.
Following the effective date of a final rule classifying these devices, any firm submitting a premarket notification (510(k)) for an HSV 1 or 2 or HSV 1 and 2, serological assay will need to address the risks covered in the special control guidance document. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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New FDA Draft Guidance, Performance Criteria for In-Vitro Diagnostics, H.Pylori

Posted on October 14, 2010 by admin| Leave a comment

New FDA Draft Guidance, Performance Criteria for In-Vitro Diagnostics, H.Pylori

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FDA is issuing this draft guidance to provide industry and agency staff with updated recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs) intended to be used for detecting Helicobacter pylori (H. pylori). The document is a revision of the guidance entitled “Guidance for Industry and FDA Staff: Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori” that was issued on September 17, 1992. It is updated to include alternate test methods, other than antibody-based detection, that are currently being used to detect H. pylori. Such methods, discussed in this document, include the stool antigen test, the urease test, blood and urine antibody tests, and the carbon-urea breath test.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA Publishes Q&A on Humanitarian Device Exemption (HDE) Regulation

Posted on October 3, 2010 by admin| Leave a comment

FDA Publishes Q&A on Humanitarian Device Exemption (HDE) Regulation.

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This guidance document answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for Humanitarian Device Exemption (HDE) authorized by section 510(m)(2) of the Federal Food, Drug, and Cosmetic Act (the Act). This guidance document reflects the additional requirements set forth in the Pediatric Medical Device Safety and Improvement Act of 2007.
For the purposes of this guidance, “you” refers to the HDE holder, the Institutional Review Board (IRB), or the clinical investigator depending upon how the question is asked and “we” refers to FDA.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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