Author Archives: damienbove

FDA publish guidance on responding to unsolicited requests for off label information about prescription drugs and medical devices

Posted on February 3, 2012 by damienbove| Leave a comment

The FDA is published guidance on the current thinking on how manufacturers and distributors of prescription medicines and devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use generally known as off label information related to FDA approved products.

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Posted in labeling, marketing

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FDA Publish Guidance on IDEs and INDs for Repair or Replace Knee Cartilage

Posted on February 2, 2012 by damienbove| Leave a comment

This guidance document provides answers of investigational device exemption application (IDE) on investigational new drug application (IND) recommendations about the information they need to include within their submission on describing their products but is intended to replace or repair knee cartilage.

This guidance supplements other recommendations in the area of drugs and biologicals and devices provide recommendations specific to cartilage repair or replacement. the FDA considers these products a significant risk area, and requires you to have specific approval from the FDA conducting research in this area. Advice from the institutional review board is no longer sufficient.

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Posted in clinical, devices

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Normal Service to Resume Soon

Posted on January 31, 2012 by damienbove| Leave a comment

Apologies to my readers the site has gone quite in January, I have been on Paternity leave so unable to update the site, I have started recruiting an assistant to keep on-top of things but as yet not had much luck. Normal service resumes in February.

Best Regards

Damien

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Posted in Uncategorized

FDA publishes guidance on responding to unsolicited requests for off label information

Posted on January 9, 2012 by damienbove| Leave a comment

This guidance is a representation of the FDA’s current thinking how manufacturers and distributors of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off label information).

This updates previous guidance and clarifies FDA’s policies, in light of emerging electronic media.

Full guidance reproduced below:

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Posted in marketing, regulatory

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NICE published detailed review of service user experience in adult mental health

Posted on January 8, 2012 by damienbove| Leave a comment

The report subtitled proven experience of care for people using adult NHS mental health services is published by NICE and is aimed to advise on improving the experience of care for people using mental health services.

The report delivers a number of recommendations and has been developed by multidisciplinary team of health care professionals, service users, their carers and guidance methodologiesafter careful consideration of the best available evidence.

Although the evidence business area is continually expanding the number of major gaps and future revisions of this guidance will incorporate new scientific evidence as it develops.

This guidance goes on to make a number of research recommendations specifically to address gaps in the evidence base.

This highly detailed report is available to download from the following link NICE report

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Posted in market access

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NICE published guidance on Elucigene FH20 and LIPOchip for the diagnosis of familial hypercholesterolaemia

Posted on January 7, 2012 by damienbove| Leave a comment

Elucigene FH20 and LIPOchip are not recommended for the confirmation of the clinical diagnosis in people with familial hypercholesterolaemia because greater benefits can be achieved cost effectively through the use of comprehensive genetic analysis. They are also not recommended for Cascade testing relatives of people with confirmed familial hypercholesterolaemia because targeted sequencing is less expensive and can be used with no loss of health benefits.

Full guidance given below

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Posted in market access

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NICE published guidance on Panitumumab in combination with chemotherapy for metastatic colorectal cancer

Posted on January 6, 2012 by damienbove| Leave a comment

NICE is unable to recommend the use of Panitumumab in the NHS in combination with chemotherapy for the treatment of metastatic colorectal cancer. The manufacturer did not submit any evidence to NICE during this technology evaluation.

This evaluation relates only to wild-type KRAS metastatic colorectal Cancer first-line treatment with FOLFOX and second-line treatment in combination with FOLFIRI for patients who received first line fluoropyrimidine-based chemotherapy.

full guidance given below

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Posted in market access

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NICE Publish Guidance on the use of Fulvestrant for the treatment of locally advanced or metastatic breast cancer

Posted on January 5, 2012 by damienbove| Leave a comment

Fulvestrant it’s not recommended, with its licensed indication, as an alternative to aromatase inhibitors for the treatment of oestrogen receptor positive, locally advanced metastatic breast cancer in postmenopausal women whose cancer has relapsed on or after adjuvant anti-oestrogen therapy, or who have disease progression on anti-oestrogen therapy.

Postmenopausal women currently receiving this drug should have the option to continue treatment until they or their clinicians consider it appropriate to stop.

full guidance given below

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Posted in market access

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NICE Publish Guidnace on Tocilizumab for the Treatment of Systemic Juvenile Idiopathic Arthirits

Posted on January 4, 2012 by damienbove| Leave a comment

NICE has published guidance on the treatment of systemic juvenile idiopathic arthritis in children and young people aged two years and older whose disease has responded inadequately to non-steroidal anti-inflammatory drugs, systemic corticosteroids and methotrexate.

If the manufacturer of Tocilizumab makes it available at discount agreed as part of the patient assessment screen then nice recommends it for use in this patient group.

It is not recommended that children and young people of disease continues to response to methotrexate or who have not been treated with methotrexate.

Children already taking tocilizumab and do not meet these criteria should have the option of continuing treatment until it is considered appropriate to stop.

for guidance given below

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Posted in market access

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NICE Publish Guidnce on Anaphlyaxis, assessment, confirmation and treatment

Posted on January 3, 2012 by damienbove| Leave a comment

Anaphylaxis is a severe life-threatening generalised systemic hypersensitivity reaction. Emergency department personel percented with a person displaying the signs ora symptoms may be classed as having a severe allergic reaction rather than an anaphylactic reaction. These NICE published guidelines intended to assist anybody who presents with such signs and symptoms to be classified as a suspected anaphylactic reaction and therefore should be diagnosed having a suspected anaphylaxis.

After an acute anaphylactic reaction it is believed that many people do not receive optimal management of their condition. One reason for this is healthcare professionals lack of understanding when making diagnosis. Another reason is a lack of understanding of when or where to refer patients. This can impact on the likelihood that the patient receives a definitive diagnosis and treatment this guideline is developed to address the situation.

Full Guidance Presented Below

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FDA published updated draft guidance on humanitarian use device designations (HUD)

Posted on December 31, 2011 by damienbove| Leave a comment

The FDA has published this guidance to assist applicants with the preparation and submission of humanitarian use device (HUD) designation requests. Requests are made to the office of orphan product development (OOPD). This guidance will also help FDA reviewers in their evaluation and analysis of HUD requests.

The topics addressed in this draft guidance include: 1) demonstrating the device is designed to treat diagnose disease or condition that affects manifesting fewer than 4000 individuals in the United States per year, 2) how this demonstration varies depending whether the device is intended for therapeutic diagnostic purposes, 3) how properties of the device may affect this demonstration and 4) delineating a medically plausible subset of patients with a given disease or condition.

full guidance given below

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Posted in devices

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FDA publishes guidance on the general principles for the development of vaccines for global infectious diseases

Posted on December 30, 2011 by damienbove| Leave a comment

The FDA is provided guidance to assist sponsors in developing vaccine to protect against global infectious diseases. The guidance focuses on development of licence of vaccines for infectious diseases or conditions endemic in areas outside the United States. It aims to clarify regulatory status and guidance already published for development of these products.

Full guidance given below

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Posted in clinical, pre-clinical

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FDA publishes questions and answers and change requestson M2: eCTD specifications

Posted on December 29, 2011 by damienbove| Leave a comment

This Excel file contains change history and the breakdown of our questions submitted on eCTD structure and specifications.

This file should be viewed in Excel and can be downloaded from the FDA website

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Posted in regulatory

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FDA published guidance on the regulatory classification of pharmaceutical Co-Crystals

Posted on December 28, 2011 by damienbove| Leave a comment

This guidance is being developed for applicants of new drug application is an abbreviated drug applications in order to give them an insight into the agency’s current thinking on the classification of co-crystal solid-state forms. It also provides information about the data that should be submitted to support the appropriate classification and the regulatory implications of classification.

Full guidance given below

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Posted in manufacturing

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FDA produces guidelines on the use of nucleic acid test on pooled and individual donor samples to reduce risk of hep B transmission

Posted on December 27, 2011 by damienbove| Leave a comment

This guidance is being provided to blood establishments that collect whole blood and blood components for transfusion or other manufacturing. The FDA recommends the use of FDA licensed nucleic acid test to screen blood donors hepatitis B virus DNA. This guidance also provides recommendations for blood testing and disposition, Doner Management, methods of Donerrequalification and product labelling.

Full guidance provided below

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Posted in biotechnology, manufacturing

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FDA releases guidance on the re-qualification method for re-entry of donors who test positive for hepatitis B following vaccination

Posted on December 26, 2011 by damienbove| Leave a comment

This guidance is intended for blood establishments the manufacturer whole blood and blood components including source plasma and source leucocytes. It provides guidance for the re-qualification method or process for the re-entry of deferred donors who test repeatedly reactive for hepatitis B surface antigens, confirmed positive by neutralisation, following a recent vaccination for hepatitis B infection, and who are not infected by hepatitis B virus.

Full guidance given below

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Posted in biotechnology, market access

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FDA published guidance on the nonclinical evaluation of therapeutic radiopharmaceuticals

Posted on December 25, 2011 by damienbove| Leave a comment

The FDA is provided this guidance in order to make recommendations to industry for describing the nonclinical late radiation toxicity studies to determine potential late radiation effects of therapeutic radiopharmaceutical agents. This is to help minimise the risk of late occurring radiation toxicities in clinical trials. Other guidance are available for conventional non-safety studies but this guidance focuses solely on late radiation safety concerns that are unique to therapeutic radiopharmaceuticals. The unique safety concerns result from the risk of irreversible toxicity when these agents deliver high dose of ionising radiation to normal organs.

full guidance given below

 

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Posted in pre-clinical

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NICE publishes guidance on balloon dilation of the Eustachian tube

Posted on December 24, 2011 by damienbove| Leave a comment

It is the opinion of NICE that the current evidence on the efficacy and safety of balloon dilation of the eustachian tube is inadequate in quality and quantity. This procedure should only be used in the context of research, that’s addressing efficacy of the procedure in the short and long-term and documenting safety outcomes. Any research subjects should be aware of the experimental nature of the procedure.

 

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Posted in market access

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NICE publishes guidance on closure of anal fistula using a suturable boiprosthetic plug

Posted on December 23, 2011 by damienbove| Leave a comment

NICE has replaced previous guidance on on the closure of anal fistulas with bioprosthetic plugs with this new document. The use of the technique raises no major safety concerns however evidence efficacy is inadequate in terms of quality and quantity. Therefore it is the opinion of NICE that the procedure should only be used with special arrangements for clinical governance, consent and audit or research.

Full guidance is given below

 

 

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Posted in market access, Uncategorized

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NICE published guidelines on endoscopic transluminal pancreatic necrosectomy

Posted on December 22, 2011 by damienbove| Leave a comment

NICE has concluded that endoscopic transluminal pancreatic necrosectomy shows the potential for serious complications. Evidence of small number of patients are shown that it is efficacious, but repeated procedures are often required. So this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

Nice has concluded that clinicians wishing to undertake this procedure should inform the clinical governance leads in their trusts ensure patients understand the uncertainty about the procedure safety and efficacy and audit and review the clinical outcomes.

Before guidance is given below [Private]

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Posted in market access

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