FDA Policy/General

Latest Federal Register Notices

Draft Guide on Major Depressive Disorder Drugs
Federal Register notice: FDA makes available a draft guidance for industry entitled “Major Depressive Disorder: Developing Drugs for Treatment.” 06/22/2018

Next Gen Sequencing Tumor Profiling Test in Class 2
Federal Register notice: FDA classifies the next-generation sequencing-based tumor profiling test into Class 2 (special controls). 06/22/2018

Draft Guidance on Drug User Fee Waivers
Federal Register notice: FDA makes available a draft guidance entitled “Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.” 06/21/2018

Antimicrobial Drugs Panel to Review 2 NDAs
Federal Register notice: FDA announces an 8/8 Antimicrobial Drugs Advisory Committee meeting two review two Paratek Pharmaceuticals NDAs. 06/21/2018

Info Collection Extension for Adverse Event Reporting
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” 06/20/2018

FDA Withdraws Approval of 5 NDAs
Federal Register notice: FDA has withdrawn the approval of five NDAs from multiple applicants. 06/20/2018

Several Information Collections Approved by OMB
Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget. 06/19/2018

Draft Guide on Nonclinical Anticancer Trials
Federal Register notice: FDA makes available a draft guidance entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals — Questions and Answers.” 06/19/2018

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