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New FDA Guidance on Polymorphic Compounds in Generic Drugs
July 12th 2007A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.
Senators Draft Legislation for Follow-On Biologics Approval
June 28th 2007Washington, DC (June 22)-Senators Orrin Hatch (R-UT), Edward Kennedy (D-MA), Michael Enzi (R-WY), and Hillary Clinton (D-NY) agreed on legislation that would authorize the US Food and Drug Administration (Rockville, MD) to approve follow-on versions of biologic therapies.
European Medicines Agency Addresses Viracept Recall; Recommends Suspending Marketing Authorization
June 28th 2007June 21 (London)-The European Medicines Agency agreed to follow up with patients affected by Roche Registration Limited's (Basel, Switzerland) "Viracept" (nelfinavir), which was recalled earlier this month. The drug, an antiretroviral medicine used to treat HIV-1 infected patients older than three years, was recalled from the European market after it was learned that some batches had become contaminated with ethyl mesilate during manufacturing.
FDA, EMEA, EC Extend Regulatory Collaboration Efforts
June 21st 2007Rockville, MD (June 18)-The US Food and Drug Administration, the European Commission, and the European Medicines Agency have agreed to extend cooperative activities to the areas of pediatrics and medicinal products for rare diseases (i.e., orphan drugs).
Court Upholds Sanofi-Aventis's Plavix Patent
June 21st 2007New York (June 19)-The US District Court for the Southern District of New York affirmed the validity and enforceability of Sanofi-Aventis's patent on clopidogrel bisulfate, the active ingredient in the company's coronary artery disease treatment "Plavix."
FDA Issues Draft Guidances for Online Access of Bioequivalence Studies for Generic Drugs
June 7th 2007Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).
New FDA Advisory Committee Will Address Risk Communication to the Public
June 7th 2007Rockville, MD (June 4)-Americans may soon have access to more information about the risks and benefits of the prescription and over-the-counter drugs they take. The US Food and Drug Administration is establishing an advisory committee to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.