Drugs

Guidance on GDUFA Division Reconsideration Requests

FDA has issued a draft guidance, Requests for Reconsideration at the Division Level Under GDUFA, with recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and ANDA applicants at the division level or original signatory authority. The document does not describe the format dispute resolution process for resolving scientific and/or regulatory disputes between FDA and sponsors or applicants that cannot be resolved through the request for reconsideration process at the division level. It also does not describe the procedures for resolving administrative matters, such as disputes over user fee assessments.

The agency says the procedures and policies described in the draft guidance are intended to formalize its current and historical practices, and to continue to promote rapid and fair resolution of scientific and/or regulatory disputes between an applicant and FDA. It covers information for applicants to consider before pursuing a request for reconsideration, procedures for submitting a request for reconsideration, and the agency’s process for responding to a request.

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