Drugs

First-Cycle Drug Approvals Improve: Report

CDER “first-cycle” drug approvals in 2023 shot up to 84% (46 of 55 NDAs) from 76% (28 of 37 NDAs) in 2022, according to a just-released report entitled Advancing Health Through Innovation: New Drug Therapy Approvals 2023. “This high percentage is in part reflective of the extent to which CDER staff provide clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive drug assessment,” the report says.

Of the 55 novel drugs approved last year, the report says 51% (28 NDAs) received orphan drug designations because they target rare diseases. This is slightly down from last year when 54% (20 of 37 NDAs) of the approvals were orphan drugs.

On the user fee front, 49 of the 55 (89%) NDAs approved last year met or exceeded goal dates for 49 of these approvals (89%). In comparison, CDER met or exceeded its goal dates for 36 of 37 the novel drugs approved (97%) in 2022. The report also adds that a number of novel drug approvals in 2023 were delayed due to Covid-19 foreign inspection restrictions.

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