Drugs

5 GDUFA 3 Reauthorization Meeting Summaries

FDA has released its summaries from five GDUFA 3 reauthorization meetings. The summaries with discussion topics were:

March 25 – Continued clarifying discussions around shared proposals related to drug master files; FDA proposals to streamline annual reporting commitments; the role of inspections in meeting the requirements for a complete review; and industry thoughts on the FDA resources needed proposal.
April 1 – Continued discussions of the implementation of the Inactive Ingredient Database; the role of inspections in meeting the requirements for a complete review; streamlining annual reporting commitments; FDA proposals intended to set a sound foundation for continued programmatic success.
April 8 – Drug master files and streamlining annual report commitments; drafting of the GDUFA 3 commitment letter; FDA clarifying information on how a capacity planning adjuster could work in GDUFA 3.
April 15 – Continued discussion on FDA proposals intended to set a sound foundation for continued programmatic success; drug master files; criteria for a complete response when an inspection is not feasible due to a public health emergency or travel restrictions; streamlining reporting requirements; and new industry proposals on process improvements to increase earlier approvals of complex products.
April 22 – FDA clarification of proposals for setting a sound foundation for maintaining programmatic success and inspections and streamlining annual reporting requirements; industry and FDA agreed not to move forward with the Site Engagement Program; discussion of the Inactive Ingredient Database.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome