Press Release

PhRMA Statement Regarding FDA Approvals

PhRMA April 26, 2013

Washington, D.C. (November 3, 2011) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President for Scientific and Regulatory Affairs Dr. David E. Wheadon issued the following statement today on FDA’s report, FY 2011 Innovative Drug Approvals:


“The FDA’s report on new drug approvals – finding that 35 new molecular entities received FDA approval in fiscal year 2011 – demonstrates the shared commitment of biopharmaceutical research companies and the agency to medical progress and patient care.


“By approving these new medicines, FDA is helping to provide patients with access to new medicines that offer hope in meeting unmet medical needs.  Of course, the tremendous value of these advances – and FDA’s review and approval of them – underscores the importance of expedient approval of a clean Prescription Drug User Fee Act, which will help provide the resources needed to allow FDA to continue to serve, and enhance, its essential function.”

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