Drug Development Consultant & Regulatory Consultant » FDA

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

damienbove — Fri, 30 Dec 2011 09:49:17 +0000

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

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

damienbove — Thu, 29 Dec 2011 09:46:41 +0000

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

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

damienbove — Wed, 28 Dec 2011 09:42:34 +0000

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

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

damienbove — Mon, 26 Dec 2011 15:50:54 +0000

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

FDA published guidance on the nonclinical evaluation of therapeutic radiopharmaceuticals

damienbove — Sun, 25 Dec 2011 15:46:01 +0000

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

New FDA resource: bioequivalence recommendations for specific products

damienbove — Sun, 18 Dec 2011 08:59:37 +0000

The FDA has brought together all the its bioequivalence recommendations for specific products into one online database, over the years a number of specific recommendations have been made across a large number of products. These recommendations are now brought together in a single database (currently containing 890 products) which can be accessed through the FDA website link provided below, this is specifically aimed at people developing “generic biological” products to give them an understanding of expectations of the FDA with regard to bioequivalence.

FDA thePage http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm#.TrufoqKWmLA.email

FDA published guidance on clinical considerations for therapeutic cancer vaccines

damienbove — Fri, 16 Dec 2011 08:43:46 +0000

The guidance covers critical clinical considerations for investigational studies in phase 1 and two clinical trials and phase 3 clinical trials. The guidance makes recommendations for the design of clinical trials conducted under an IND to spot subsequent biological license applications. This is finalisation draft guidance was published in September 2009.

the product discussed in this guidance are therapeutic cancer vaccines intended to result in specific responses to tumour antigens and are intended to treat patients with an existing cancer. These products are traditionally regulated by the Centre for Biological Evaluation Research (CBER) and are referred to as cancer vaccines throughout this document.

EMA and FDA set up Biosimilar Cluster and Publish Report

admin — Wed, 28 Sep 2011 09:22:26 +0000

EMA and FDA set up Biosimilar Cluster and Publish Report

Full Text Here

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on biosimilar medicines.

Clusters are topic areas of mutual interest for the two agencies, which they have identified as benefiting from the regular exchange of information and collaborative meetings. Biosimilar medicines is the latest addition to the existing list of topics, which already includes medicines to treat cancer, orphan medicines, medicines for children and blood-based products.

The new cluster will allow the two agencies to increase their degree of interaction and will begin with a kick-off meeting to discuss the group’s activities. The group will follow this with discussions by teleconference around three times a year.

This is the latest step in the two agencies’ ongoing collaboration on regulatory issues under their confidentiality arrangements, which they first signed in 2003. The degree of interaction between the EMA and the FDA has increased significantly since then, to the current stable level of around 55 interactions per month, according to the first report on interactions between the two agencies, published today.

The report, which covers regular and ad-hoc interactions, emphasises the close level of collaboration between the two agencies, including the exchange of staff and regular staff visits, the co-ordination of communication on high-profile issues and the exchange of information on topics of shared interest.

The agencies plan to issue an report on their interactions every year.

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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 Announces Joint FDA Workshop on Orphan Designation

admin — Tue, 13 Sep 2011 11:31:08 +0000

EMA Announces Joint FDA Workshop on Orphan Designation

Full Text Here

The aim of this workshop is to provide regulatory assistance to sponsors developing orphan drug designation applications.

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FDA wants to transform into a global agency

admin — Tue, 05 Jul 2011 09:11:43 +0000

FDA wants to transform into a global agency

According to the FDA half for all medical devices used in USA are imported while 80% of active pharmaceutical ingredients sold in the US and manufactured elsewhere, and this trend is increasing.

The FDA has unveiled a new global strategy to help ensure the safety and quality of imported products and increasingly complex global supply chain..

” global production of FDA regulated goods exploded over the past 10 years. In addition to increasing import finished products, manufacturers increasingly use imported materials ingredients in a US production facilities, making the distinction between domestic and imported products obsolete” said Margaret Hamburg Commissioner of the FDA. A dramatic change in strategy must be implemented.

According to the report published by the FDA the FDA’s international operating model will rely on enhanced intelligence, information sharing, data driven risk analysis, and smart allocation of resources through partnerships.

the new approach will rest on four core building blocks:

FDA to partner with its counterparts worldwide to ensure and improve global product safety and quality
FDA needs partners to develop an international data information systems and networks to promote the sharing of data and regulatory resources.
FDA to develop additional information gathering with increased focus on risk analysis
FDA to leveraged the efforts of third parties and industry and a portion FDA resources based on risk.

This is another example of increasing globalisation pharmaceutical industry, regulators and no longer operating geographically distinct silos, by reaching out to each other to enforce strict adherence to ICH based regulatory perspectives. Other examples of this include joint EU FDA evaluation processes for orphan drugs, manufacturing quality, and quality by design. Where will this trend lead remains to be seen, but it is clear that everybody operating the pharmaceutical, biotechnology and medical devices industies needs to think globally.

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