ANDA Review Time Cuts Possible Without User Fees, Barr Rep Says
This article was originally published in The Tan Sheet
Executive Summary
FDA's Office of Generic Drugs could reduce ANDA review times by adding 50 full time equivalents, Barr Laboratories CEO Bruce Downey told the House Energy & Commerce/Health Subcommittee June 13.You may also be interested in...
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FDA does not have an established procedure in place to prevent the disclosure of protected trade secrets in the event of a forced Rx-to-OTC switch, Center for Drug Evaluation & Research Director Janet Woodcock, MD, told a House panel June 13.
FDA Forced OTC Switch Process Ambiguities Revealed At Subcmte. Hearing
FDA does not have an established procedure in place to prevent the disclosure of protected trade secrets in the event of a forced Rx-to-OTC switch, Center for Drug Evaluation & Research Director Janet Woodcock, MD, told a House panel June 13.
FDA Forced OTC Switch Process Ambiguities Revealed At Subcmte. Hearing
FDA does not have an established procedure in place to prevent the disclosure of protected trade secrets in the event of a forced Rx-to-OTC switch, Center for Drug Evaluation & Research Director Janet Woodcock, MD, told a House panel June 13.
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