Drugs

2 ANDA Guidances Out

FDA has issued two draft guidances dealing with changes resulting from the GDUFA 2 reauthorization agreement. The first guidance, ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA, explains to applicants how the review goals established as part of the Generic Drug User Fee Amendments reauthorization apply to amendments to either ANDAs or prior approval supplements (PASs) submitted to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act. The document describes amendment classifications and categories and explains how amendment submissions may affect an application’s review goal dates. It also describes how FDA should review amendments submitted to ANDAs and PASs received before the 10/1 GDUFA 2 review goals effective date.

The second draft guidance, ANDA Submissions—Refuse-to-Receive Standards, is intended to assist applicants preparing to submit to FDA ANDAs and certain PASs. The document provides answers to questions the agency has received from applicants about an earlier guidance and the filing review process in general. The questions and answers are said to address general issues about the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to drug master files, product quality, and bioequivalence, and clinical reviews. It is intended to clarify the deficiencies that may cause FDA to refuse to receive an ANDA, the agency says.

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