Drugs

FDA Resumes Generic Drug In-person Meetings

FDA says that it is now resuming in-person face-to-face (FTF) meetings with generic drug industry members in a “phased-in approach” while also allowing the option to hold a videoconference meeting. “Initially, the in-person FTF meeting option will only be available for pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format,” an FDA notice says. The FTF meetings may be limited by facility capacity and logistical considerations, the agency says, adding that such meeting requests that can’t be accommodated will be conducted by videoconference.

F meeting must be part of the initial meeting request package received on or after 3/27. “In-person FTF meetings will be hybrid with small delegations from FDA in the meeting room — with industry members, other FDA staff, and industry video conferenced into the room,” it says. “FDA will focus on having only core participants with a primary speaking role in-person while others will join virtually.”

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