Drugs

Office of Generic Drugs 2022 Highlights

The 2022 CDER Office of Generic Drugs (OGD) Annual Report outlines many highlights during the year, concurrent with the GDUFA 3 reauthorization. OGD approved or tentatively approved 914 ANDAs, participated in 108 pre-ANDA meeting requests, issued 257 product-specific guidances, issued 1,775 complete response letters detailing deficiencies before an ANDA could be approved, and published 31 new policy documents. In the report, OGD acting director Susan Rosencrance says the implementation of FDA’s commitments under GDUFA 3 is “bringing the program to yet another level. It will build on the successes of the GDUFA 1 and GDUFA 2 programs, with a focus on reducing the number of assessment cycles to advance earlier approvals and promote the timely availability of generic medicines.”

Highlights detailed in the report are:

renewal of GDUFA;
scientific research;
international collaborations;
regulatory science education;
generic drug approvals;
first generics;
significant first generic approvals in 2022; and
communicating with industry.

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