Monthly Archives: November 2009

Drug Regulators, EMEA, Publish Guidance on the Development of therapies for Cystic Fibrosis

Posted on November 30, 2009 by admin| Leave a comment

Drug Regulators, EMEA, Publish Guidance on the Development of therapies for Cystic Fibrosis

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CF is a life threatening and chronically debilitating disease, impairing the Quality of life, characterised by progressive bronchiectasis and obstructive pulmonary disease (> 90% patients). The lower respiratory tract involvement is the primary cause of morbidity and mortality in patients with CF (> 90% of fatalities). Ninety percent of CF patients are colonised with Pseudomonas aeruginosa (PA), and PA infections are the cause of mortality in 80% of those patients.

CF is mainly a paediatric disease. Life expectancy is considerably shortened due to respiratory damage-induced morbidity and mortality. However, due to the advances of past 20 years in the prophylaxis of chronic respiratory infection, along with the systematic supplement of pancreatic enzyme and decrease in malnutrition CF patients reach a mean 30 to 40 years of age, and the proportion of adult CF patients increases.

The guidance will focus on:
• clinical trials design in lung involvement and clinically relevant endpoints (mucociliary clearance and broncho-pulmonary infections (mortality), in particular: treatment of PA early colonisation, chronic infection and exacerbations; prophylaxis of chronic PA infection; slowing/stopping lung damages (fibrosis, bronchiectases)
• clinical trials design in pancreatic involvement, in particular management of exocrine pancreatic insufficiency and malnutrition.

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Twitter Weekly Updates for 2009-11-29

Posted on November 29, 2009 by admin| Leave a comment
  • Market access issues are central to indication selction and central to market access is an understanding of the treatment pathways #
  • Wow the drug/biotech regulations change so quickley. Go to damienbove.com for our free regulatory watch service. #
  • Desk research in medical technologies from 350per day. Markets, deals, suppliers, liturature, people, companies, or anything you want #
  • We won a yorkshire forward award for excellence in mentoring new start up businesses. A great reflection on our work #

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Drug Regulators, FDA CDER, Publish Updated Guidance on Investigator Responsibilities for Study Subjects

Posted on November 24, 2009 by admin| Leave a comment

Drug Regulators Publish Updated Guidance on Investigator Responsibilities for Study Subjects

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This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). The goal of this guidance is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. This guidance is intended to clarify for investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights, safety, and welfare of study subjects.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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Drug Regulators, FDA (CDER), Publishes Guidance on SPL Standard for Content of Labeling Technical Qs & As

Posted on November 23, 2009 by admin| Leave a comment

Drug Regulators, FDA (CDER), Publishes Guidance on SPL Standard for Content of Labeling Technical Qs & As

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This guidance is intended to assist applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup language (XML). The guidance also provides information to FDA staff who review and manage product information using electronic systems. This is revision 1 of a guidance of the same name that was issued in December 2005. The guidance has been revised to reflect changes in the technology since 2005 and to harmonize the submission of SPL in the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). We anticipate that additional guidance will be provided as new questions arise about the use of SPL in different contexts.
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.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA (CDER), Publishes Guidance on SPL Standard for Content of Labeling Technical Qs & As

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Twitter Weekly Updates for 2009-11-22

Posted on November 22, 2009 by admin| Leave a comment
  • DILI the FDA liver tox regulations take a pragmatic stance on liver tox. If your going to save your product you need our expert review #

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European Commission Publishes Assessment of the Functioning of the Clinical Trials Directive

Posted on November 22, 2009 by admin| 1 Comment

European Commission  Publishes Assessment of the Functioning of the Clinical Trials Directive

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In its Communication of 10 December 2008 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector”, the Commission announced that an assessment would be made of the
application of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (“Clinical Trials
Directive”).

This assessment would consider, in particular, various options for further improving the functioning of the Clinical Trials Directive with a view to remedy shortcomings and unintended negative consequences while taking the global dimension of clinical trials into account.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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ida consultants freestrategyconsultation 515x64 European Commission Publishes Assessment of the Functioning of the Clinical Trials Directive

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Drug Regulator, EMEA, Publishes ICH Guidance on the use of Oncolytic Viruses

Posted on November 21, 2009 by admin| Leave a comment

Drug Regulator, EMEA, Publishes ICH Guidance on the use of Oncolytic Viruses

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Oncolytic viruses (OV) were first observed in early clinical studies in patients with malignancies where tumour regressions were observed to coincide with viral infections or with live virus vaccinations. Since these early reports, studies using OV have progressed from anecdotal and controlled infections to specifically selecting or genetically modifying viruses for cancer treatment. OV are intended to replicate selectively in tumour tissue and spread, destroying the tissue without causing excessive damage to normal tissues.
OV can be wild type or naturally attenuated strains of viruses that possess an inherent property of selective replication and lysis of cancer cells. Additionally, viruses can be genetically modified to selectively replicate and lyse cancer cells. These modifications can include 1) the mutation of the viral coding genes that are critical for viral replication in normal cells, 2) the control of early gene expression by using tumour-specific promoters, 3) a change in the viral tissue tropism and/or cell entry process, and 4) the incorporation of transgenes into the viral genome. Examples of OV include adenovirus, measles virus, vesicular stomatitis virus (VSV), reovirus, Newcastle disease virus, herpes simplex (HSV), poxvirus, Sendai virus, and others.
Regulatory authorities represented at the ICH agree that the therapeutic potential of OV will need to be balanced against the risks associated with the use of virus that is replication competent. This document identifies general principles for the clinical development of OV.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulator, EMEA, Publishes ICH Guidance on the use of Oncolytic Viruses

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Liver Toxicity, FDA DILI Regulations Require Interpretation

Posted on November 20, 2009 by admin| Leave a comment

Save Your Project from an Unjust Death

Signs of liver toxicity from experimental results can mean that a project is killed or investors walk away, but this is often an inappropriate response. Liver toxicity is a highly complex issue and in an attempt to provide some light on the issue the FDA has recently published guidelines on Drug Induced Liver Injury (DILI). These guidelines set the regulatory standard and take a very pragmatic position on liver tox and encourage industry to likewise take a pragmatic view.

However Companies need help in reviewing data and taking that pragmatic view, in response to this IDA consultants have made available a number of experts to provide the review that will help you:

  • DON’T kill your project without good cause
  • DO understand what the data actually means
  • PLACE your results in therapeutic context
  • REASURE investors with expert opinion

Liver Toxicity Data Review and Expert Opinion

Worrying liver tox results can come from a number of sources:

  • Pre-Clinical
  • Clinical
  • In-Vitro
  • Metabolite Studies
  • Class effects

IDA consultants has arranged a group of high caliber experts, all with masses of FDA and EMEA experience who can review your data and make recommendations that put it in context of the DILI regs and the therapeutic / technology risk profile:

  • PK/PD
  • Standards of Care
  • Co-morbidities
  • Product specific factors
  • Risk/Benefit ratio

Re-capture the value in your project

The outcomes of this work is an expert report that puts the Liver tox data in context, and puts the value back in your technology. The expert report is of a standard suitable for investors, and regulators alike.

This review can save your project from an un-just death, and is available from £7000. The first step is to organize a Free review so you can understand the options available for your technology without spending a penny.

Get in touch for your free Consultation.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Liver Toxicity, FDA DILI Regulations Require Interpretation

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators, EMEA, Re-Publish Guidance on Special Populations Geriatrics

Posted on November 20, 2009 by admin| Leave a comment

Drug Regulators, EMEA, Re-Publish Guidance on Special Populations Geriatrics

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It is important to ensure that clinical testing programs are carried out according to harmonised guidelines based on agreed ethical and scientific principles so that the international development of valuable innovative drugs is achieved with maximum efficiency. Harmonisation in relation to medicines for geriatric populations is an important issue because the total population of the elderly will increase significantly in the coming years in Europe, Japan and the USA. The use of drugs in this population requires special consideration due to the frequent occurrence of underlying diseases, concomitant drug therapy and the consequent risk of drug interaction.

This guideline is directed principally toward new Molecular Entities that are likely to have significant use in the elderly, either because the disease intended to be treated is
characteristically a disease of aging ( e.g., Alzheimer’s disease) or because the population to be treated is known to include substantial numbers of geriatric patients (e.g., hypertension). The guideline applies also to new formulations and new combinations of established medicinal products when there is specific reason to expect that conditions common in the elderly (e.g., renal or hepatic impairment, impaired cardiac function, concomitant illnesses or concomitant medications) are likely to be encountered and are not already dealt with in current labelling. It likewise applies when the new formulation or new combination is likely to alter the geriatric patient’s response (with regard to either safety/ tolerability or efficacy) compared with that of the non-geriatric patient in a way different from previous formulations. The guideline also applies to new uses that have significant potential applicability to the elderly.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, EMEA, Re Publish Guidance on Special Populations Geriatrics

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How much does the tax man owe you?

Posted on November 19, 2009 by admin| Leave a comment

You can now  get  tax free CASH BACK! – R&D tax credit rules have changed so even more companies can claim money from the Tax Man

There is an R&D Tax Credit for you if you are;-  Developing  new products,new science, New Services,New Software, or Large Engineering projects? , SO don’t miss out.

Get in touch NOW ! IDA has been working closely with Armstrong Watsons R&D Tax credit expert and frankly we are BLOWN AWAY by the size and scope of the new opportunities. contact  Nigel Holmes, if you’re a Limited company doing R&D or new product development, Nigel will tell you quickly how much cash you are due.

Even if you receive a grant towards R&D you can get the R&D tax relief too!

Fill in the form below and get our free guide, or if you can’t wait pick up the phone –  01228 690200 and Nigel will educate you as well.

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Medical Device Regulators Publish Guidance on Vigilance Systems Breast Implants

Posted on November 19, 2009 by admin| Leave a comment

Medical Device Regulators Publish Guidance on Vigilance Systems Breast Implants

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This guidance document gives advice to manufacturers on the notification of adverse incidents involving breast implants under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, and the MHRA’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.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Medical Device Regulators Publish Guidance on Vigilance Systems Breast Implants

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IDA adds Herbal Medicines Expertise to Offerings

Posted on November 18, 2009 by admin| Leave a comment

IDA adds Herbal Medicines Expertise to Offerings

Associate consultant Chantel McGrath (BA, BSC) joins the IDA team. She is a fully qualified medical herbalist and who provides regulatory consultancy on the herbal medicine sector. She has 5 years of experience in producing market research and analysis reports and has built a strong reputation for delivering concise market intelligence and analysis-for clients keen to understand market entry opportunities and barriers in the UK and overseas, with a strength in finding information that is not readily available; simplifying complex legal, planning and financial processes and providing clients with comprehensive contact lists for target markets.

Her most recent work includes drafting National Institute of Medical Herbalist’s Joint-UK wide consultation on the Report to Ministers from the Department of Health steering Group on the Statutory Regulation of Practitioners of Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK and working as a regulatory and legislation advisor on herbal medicines to the various lobbying organisations.

Key Services

  • Advice and strategy on the regulatory process involved introducing herbal products through the Traditional Herbal Medicines Registration Scheme (THMRS), including finding scientific peer review research on specific herbs. Market research and planning for herbal medicine drug introduction and practice.
  • Country Market reports: Providing an overview of the political and economic climate & medical markets, Healthcare systems, regulatory environment, Legal and policy requirements, trade and business organisations, forms of distribution, general market growth forecasts and Public funding, market support mechanisms and Private investment opportunities, R & D initiatives and the competitors, Providing a contacts database of key decision makers within government departments, research institutions, trade and business organisations and manufacturers.
  • Competitor Reports: Profiles and analysis, covering key commercial indicators such as: product development, market placement, technological or biotechnical viability, consent status, staffing, published company accounts, funding & investment and full analysis of the client’s position within this market.
  • Design and Concept Reports: Providing the history and evolution of a product and reporting on the predictable and future innovations to aid product conception and development.
  • Advertising Support: Photo research and slogans for products, advertising copy and design, flyer design, promotional materials and recruitment drives.

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Posted in Herbal

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Drug Regulators, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications

Posted on November 16, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications

Full text Hear

The Center for Biologics Evaluation and Research (CBER), FDA, are recommending ways that would allow the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for specified indications. This guidance document is intended to assist you in obtaining a biologics license. It contains information about the manufacture of minimally manipulated, unrelated, allogeneic placental/umbilical cord blood and how to comply with applicable regulatory requirements.
This guidance finalizes the draft guidance entitled “Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies,” dated December 2006.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications

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Twitter Weekly Updates for 2009-11-15

Posted on November 15, 2009 by admin| Leave a comment
  • Orphan drug designations and stratifications, require demonstartion of plausibility in the target group, but also positive elimination! #
  • Sme stauts with the EMEA attracts a 90% discount on scientific advice fees. #
  • Ethis in phase 1 clinical research white paper launched on http://www.damienbove.com/medqp/ #

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Drug Regulators, FDA, Publish Draft Guidance on IND’s for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood

Posted on November 14, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Draft Guidance on IND’s for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood

Full Text Hear

The Center for Biologics Evaluation and Research (CBER), FDA, are providing advice to potential sponsors (e.g., generally cord blood banks, or registries, and individual physicians serving as sponsor-investigators) to assist in the submission of an investigational new drug application (IND) for certain hematopoietic progenitor cells, cord (HPC-C), when such HPC-Cs are not licensed in accordance with 21 CFR 601, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for treatment of a patient with a serious or life-threatening disease or condition and there is no satisfactory alternative treatment. If unlicensed HPC-Cs are made available for clinical use, they must be distributed under an IND meeting the applicable requirements in 21 CFR Part 312.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.

ida 100programme 515x64 LowRes Drug Regulators, FDA, Publish Draft Guidance on INDs for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publish Draft Guidance on INDs for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood

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FDA Publishes Guidance on Circular Information for the Use of Human Blood and Blood Components

Posted on November 13, 2009 by admin| Leave a comment

FDA Publishes Guidance on Circular Information for the Use of Human Blood and Blood Components

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The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by, manufacturers of blood and blood components intended for transfusion subject to United States statutes and regulations the instruction circular entitled “Circular of Information for the Use of Human Blood and Blood Components” (Circular) dated August 2009. The August 2009 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion. We believe that the Circular will assist you in complying with labeling requirements under 21 CFR 606.122 (§ 606.122). The requirements under § 606.122 specify that an instruction circular must be available for distribution with blood and blood components intended for transfusion. Section 606.122 further specifies the information that is required in the instruction circular. This guidance supersedes the guidance of the same title dated December 2003.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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The Ethics of Phase 1 Research in Patients

Posted on November 12, 2009 by admin| Leave a comment

The Ethics of Phase 1 Research in Patients

IDA Medical Director Tony Lockett has completed a review of the Ethics of Phase 1 Research in Patients, this report examins the ethical arguments revolving around the use of patients for first-in-man clinical studies, this is increasingly becoming a very important issue.

To get a copy of this free report, simpley fill out the form below or send a blank email to ethics@damiebove.com

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Drug Regulators, FDA, Publish a Good Review Practice Guidance for Labeling for Human Prescription Drug and Biological Products

Posted on November 12, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish a Good Review Practice Guidance for Labeling for Human Prescription Drug and Biological Products

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This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling. Although not specifically required, the pharmacologic class can also appear in other sections of labeling. This guidance only applies to the use of the pharmacologic class in the Indications and Usage section of Highlights.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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Drug Regulators Publish Concept Paper on the Need to Revise Clinical Guidance for Depression

Posted on November 11, 2009 by admin| Leave a comment

Drug Regulators,EMEA, Publish Concept Paper on the Need to Revise Clinical Guidance for Depression

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Major Depressive Disorder (MDD) is one of the most common psychiatric disorders, which is the fourth leading cause of global disease burden and affects about 15 % of the general population. As outlined in the guidance document MDD is not a benign disorder and risk of suicide is considerable. Although a broad therapeutic armamentarium for treatment of major depressive episodes (MDE) is available, still about one-third of patients treated for the condition do not respond satisfactorily to the first antidepressant described. Incomplete treatment response or treatment resistance have been described commonly in up to 30 % of the treated patient population, and may even as high as 60 % if treatment resistant depression (TRD) is defined as absence of remission. However, whereas the clinical picture of TRD is common in everyday practice, the conceptual elaboration and definition of clear criteria for incomplete response and TRD has been limited. In a clinical pragmatic view a patient is considered suffering from TRD when consecutive treatment with two products of different pharmacological classes, used for a sufficient length of time at an adequate dose, fail to induce an acceptable effect. As no specific treatments have been approved for this condition and scientific data base is limited, TRD is mentioned in the guideline on treatment of depression, however, no specific guidance has been given (CPMP/EWP/518/97 rev.1). Recently new diagnostic criteria for TRD including operationalizing severity of resistance have been suggested and in scientific advice procedures possible study designs have been proposed.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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Drug Regulators EMEA publish Draft Guidance on the Use of Near Infrared Spectroscopy

Posted on November 10, 2009 by admin| Leave a comment

Drug Regulators EMEA publish Draft Guidance on the Use of Near Infrared Spectroscopy

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Near Infrared Spectroscopy (NIRS) has become a well established technique and has been used for several years in the pharmaceutical industry. The technique is useful for the identification and assay of pharmaceutical starting materials, intermediates and finished products, as well as for in-process control and monitoring purposes. NIRS constitutes one of the major methods in Process Analytical Technologies (PAT). This guideline provides guidance on the development, calibration, validation and maintenance of NIRS methods and the data to be submitted to the competent authorities when NIRS is the subject or part of a marketing authorisation application.
This guideline also clarifies and differentiates the data requirements for the marketing authorisation dossier and those for GMP, including change control.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators EMEA publish Draft Guidance on the Use of Near Infrared Spectroscopy

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