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BIO and PhRMA Submit Joint Comments to FDA on the Interim Assessment of the NME Review Program

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The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) submit these comments in response to the Federal Register notice entitled &ldquo;Interim Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket&rdquo; issued by the U.S. Food and Drug Administration (FDA).</p>

The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) submit these comments in response to the Federal Register notice entitled “Interim Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket”1 issued by the U.S. Food and Drug Administration (FDA).

PhRMA and BIO appreciate the Agency’s efforts to meet the NME Review Program’s goals as outlined in the PDUFA V Goals Letter. PhRMA and BIO appreciate the opportunity to share our thoughts on the performance of the Program to date and we look forward to continue working with all stakeholders as the Agency continues to implement the NME Review Program.