Regulatory Affairs

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September 2021 ANDA Approval Actions Slow Through the First Half of the Month

Through the last posting on the daily approval list on September 16, OGD has reported only 16 full approval actions and one tentative approval action.  If this rate keeps up through the rest of the month, we are likely to see the fewest number of monthly approval actions since the beginning of the GDUFA program. […]

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Whoops, Lots of OTC Manufacturers Missed the Deadline – FDA Releases OTC Arrears List

The FDA published its first arrears list for failure to pay FY 2021 Over-the-Counter Monograph User Fee Act (OMUFA) facility fees.  Invoices were emailed on June 25, 2021 for fees not paid by the May 10, 2021 due date.  And, holy smokes, there are almost 500 firms on the arrears list.  Twenty‑eight are contract manufacturing organizations […]

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Q&A Guidance on Development of Generic Drugs During the COVID 19 Emergency

Today, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here).  This guidance responds to questions that have been asked by sponsors since the pandemic began, covers a multitude of issues, and outlines some areas of relief for applicants.  Remember that the answers […]

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Pilot Program for Novel Excipients Announced

The use of novel excipients has potential to assist in the development of better final drug-product formulations for patients.  However, drug-product manufacturers are hesitant to use novel excipients in product development because of the uncertainty of the expectations of the FDA and, ultimately, on the FDA’s acceptance of the new excipients in its development program. […]

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PDUFA VII – Getting Ready for the Reauthorization

Today, in the pre-publication of the Federal Register (here), the Agency announced a notice of public meeting to receive comments and discuss the material negotiations that have taken place between the industry stakeholders and itself.  The notice provides an interesting historical look at the evolution of the PDUFA program since its initial 5-year iteration in […]

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