Regulatory Roundup: FDA Thanks Healthcare Workers For H1N1 Response; And More.

Published on: 

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA Thanks Healthcare Workers For H1N1 Response; And More.

Last week, US Food and Drug Administration Commissioner Margaret A. Hamburg addressed the nation’s healthcare professionals in an official letter thanking them for their efforts during the 2009 H1N1 siwne-flu outbreak. The letter noted that, as of Dec. 30, 2009, 99.3 million doses of H1N1 vaccines had been distributed and that the vast majority (94%) of adverse events reported were classified as "non-serious" (e.g., soreness at the vaccine injection site).

According to a new report form the Biotechnology Information Institutes’ online biopharmaceutical database, FDA approvals of new biopharmaceutical products increased significantly in 2009. The agency approved 16 new biopharmaceutical entities last year, the highest since 2005, says the report.


The Active Pharmaceutical Ingredient Committee(APIC) of the European Chemical Industry Council (CEFIC) reports that the Supplier Qualification and Management Guideline is available on its website. CEFIC is the trade association representing European chemical manufacturers, and APIC is a committee representing manufacturers of active pharmaceutical ingredients (APIs) and intermediates. The guidance was issued in December 2009 and is designed to share the best practices of APIC member companies on systems to be implemented to adequately manage suppliers through the complete life cycle of a product. The guideline applies to four categories: noncritical raw materials, critical raw materials (including API starting materials), registered intermediates, and APIs.