December 15, 2016
CVM Names New Center Director; Steven Solomon Assumes Directorship January 2017
The U.S. Food and Drug Administration today announced the selection of Steven M. Solomon, DVM, as the new leader of the agency’s Center for Veterinary Medicine (CVM). Dr. Solomon will assume the directorship in January 2017 from Tracey Forfa, J.D., who is currently serving as the Acting Director. Click here more information.
December 16, 2014
FDA Announces Pharmacy Compounding Advisory Committee Members
The US FDA announced the 14 members of the Pharmacy Compounding Advisory Committee responsible for providing advice on issues concerning drug compounding under the Federal FDCA. Click here for more information.
October 17, 2014
Draft GFI #227 on Two-Phased CMC Submissions Released
The U.S. Food and Drug Administration issued today draft Guidance for Industry #227: Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections, with recommendations for ways animal drug sponsors can submit chemistry, manufacturing, and controls (CMC) data to the agency to improve the efficiency of the New Animal Drug Application (NADA) review process. Click here for more information.
July 31, 2014
FDA Announces FY 2015 Animal Drug User Fee Rates for ADUFA and AGDUFA
The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2015 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2013 (ADUFA III) and Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II).
AGDUFA, originally signed into law in 2008 and reauthorized in 2013, was designed to enhance the performance of the generic new animal drug review process and enable FDA to better ensure that generic new animal drug products are safe and effective, thus giving consumers a lower cost alternative to pioneer drugs. AGDUFA II reauthorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, generic new animal drug products, and from certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. The user fees for sponsors are pro-rated based on the number of approved abbreviated applications the sponsor currently holds. AGDUFA II reauthorizes FDA to collect user fees through FY 2018.
For more information, click here.
June 30, 2014
Full Industry Engagement on FDA's Antimicrobial Resistance Strategy
Generic Animal Drug Alliance worked alongside other industry groups to support the FDA's strategy to phase out antimicrobials, garnering support among generic animal drug sponsors. Click here for more information.