Drugs

FDA Grants Covis Hearing Request on Makena

CDER has granted Covis Pharma Group’s request for a hearing on the Center’s 10/5/20 proposal to withdraw approval for Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly). An 8/18 CDER response to the Covis request grants the hearing and addresses other procedural issues related to the proposal.

The letter says FDA acting commissioner Janet Woodcock has recused herself from the proceeding based on her previous involvement in CDER’s consideration of the matter and has delegated the commissioner’s role at the hearing to FDA chief scientist Denise Hinton. Hinton says she has named CBER deputy director Celia Witten as the presiding officer for the hearing.

In the letter, Hinton says Covis has justified its request for a hearing by providing specific challenges to the factual and scientific bases underlying CDER’s proposal and including or describing data and information in support of its challenges. She directs CDER to review Covis’ request for disclosure of documents and respond within 30 days to the company’s position that FDA should disclose the “full files regarding its decision to withdraw approval for Makena” and especially categories of documents sought by Covis.

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