FDA Policy/General

Latest Federal Register Notices

Workshop on Generating Real-World Evidence
Federal Register notice: FDA announces a 7/12 public workshop entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” 06/07/2019

Nonalcoholic Steatohepatitis Drug Development Guide
Federal Register notice: FDA makes available a draft guidance entitled “Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment.” 06/07/2019

Draft Guide on Enhancing Trial Diversity
Federal Register notice: FDA makes available a draft guidance entitled “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs.” 06/07/2019

Info Collection on Tobacco Product Guidance
Federal Register notice: FDA submits to OMB an information collection extension for “Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of 2/15/2007.” 06/04/2019

FDA Priority Review Voucher Used on Mayzent NDA
Federal Register notice: FDA permits the redemption of a priority review voucher associated with the recent approval of a Novartis NDA for Mayzent (siponimod) tablets. 06/03/2019

Info Collection Extension on Supplement Notifications
Federal Register notice: FDA submits to OMB an information collection extension entitled “Food Labeling; Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93.” 05/31/2019

Comments Sought on Opioid Unit-of-Use Packaging
Federal Register notice: FDA seeks public comments on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that certain opioid analgesics be made available in fixed-quantity unit-of-use blister packaging for outpatient dispensing. 05/31/2019

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