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March 3, 2014

FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area
A new “cluster” on Pharmacovigilance topics

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.

More details online

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2014
Blood and Blood Components - Cellular, Tissue and Gene Therapy - Vaccines

There is a list of guidance topics published that CBER is considering for development during Calendar Year 2014. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 drafts that may be finalized following review of public comments. CBER currently intends to develop guidance documents on these topics; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. FDA also publishes an agency-wide Annual Guidance Agenda which includes this list and is available for public comment. See the Good Guidance Practices regulation (21 CFR 10.115) on the FDA website for details about the Annual Guidance Agenda.

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New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014
CDER is planning a number of changes to its Guidances in 2014

Planned changes and revisions as well as new issues of guidances by CDER will address many different areas and topics (see link below). Among the most important ones are with no doubt those on Biosimilars, i.e. “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product” or “Considerations in Demonstrating Interchangeability to a Reference Product” as well as Clinical/Medical guidances, i.e. “Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)” and last but not least a whole section on electronic submissions.

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Dear Healthcare Provider Letters Guidance updated
FDA released their new guidance on “Improving communication of important safety information”

This guidance provides recommendations to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence ― often in the form of a mass mailing from the manufacturer or distributor of a human drug or biologic or from FDA ― intended to alert physicians and other health care providers about important new or updated information regarding a human drug or biologic. DHCP letters may also be distributed by email and are often made available on the Internet (e.g., on company Web sites or through patient advocacy groups). This guidance provides recommendations on (1) when to issue a DHCP letter, (2) the types of information to include in a DHCP letter, (3) how to organize that information so that it is communicated effectively to health care providers, and (4) formatting techniques to make the information more accessible.

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