Drugs

Post-CRL Clarification Teleconference Guidance

FDA has published a guidance, Post-Complete Response Letter Clarification Teleconference Between FDA and ANDA Applicants Under GDUFA, with recommendations to industry on post-complete response letter (CRL) teleconferences between FDA and ANDA applicants to clarify deficiencies identified in a CRL on a section 505(j) ANDA. The document says it is important that there are efficient, consistent, procedures for the timely and effective conduct of post-CRL clarification teleconferences.

The guidance is intended to assist applicants in generating and submitting a request for a post-CRL clarification teleconference and the associated meeting package as contemplated in the GDUFA 3 reauthorization. “This guidance is intended to provide procedures that will promote well-managed post-CRL clarification teleconferences and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA reauthorization performance goals and program enhancements for FY 2023-2027,” it says.

The document revises a 12/2018 guidance to incorporate the performance goals from the GDUFA 3 reauthorization commitment letter.

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