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• FDA Unveils Its Own Medical Queries—A Standardized Approach for Grouping MedDRA Preferred Terms that

  On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics, including se…

• Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

  Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key…

• Formal Dispute Resolution: A Different Perspective on Wins and Losses

  In determining whether to submit a Formal Dispute Resolution Request (FDRR) appealing a Complete Response Letter (CRL) or other adverse action from FDA’s Office of New Drugs (OND), applicants neces…

• The 6-Year Saga Finally Ends: FDA Issues Final Rule Modifying The Intended Use Regulation

  A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices.  It is a primary basis for determining if an article is regulated by FDA at all, and if so, what r…

• The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

  Few FDA publications are as eagerly anticipated in the drug development world as the twice-a-decade PDUFA Reauthorization Performance Goals and Procedures (hereinafter the “goals letter”). When FDA…

• 505(b)(2) NDA and ANDA Amendments: Don’t Forget to Meet the New Verification Requirement

  FDA’s October 6, 2016 Final Rule implementing certain provisions of the December 8, 2003 Medicare Modernization Act (“MMA”), Pub. L. No. 108-173, 117 Stat. 2066, ushered in a lot of changes for NDA…