FDA Policy/General

Latest Federal Register Notices

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

Study Risk-Based Monitoring Approaches Workshop
Federal Register notice: FDA announces a 7/17 public workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.” 05/31/2019

Lupron Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that AbbVie’s Lupron (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn from sale for reasons of safety or effectiveness. 05/30/2019

Correction on OTC Maximal Usage Trials Docket
Federal Register notice correction: FDA corrects the docket number on a 5/10 notice entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” 05/29/2019

Info Collection on OTC Drug Labeling
Federal Register notice: FDA submits to OMB an information collection extension entitled “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” 05/29/2019

Info Collection on FDA Adverse Event Reporting
Federal Register notice: FDA submits to OMB an information collection extension entitled “FDA Adverse Event Reports; Electronic Submissions — 21 CFR 310.305, 314.80, 314.98, 314.540,329.100,514.80, 600.80, 1271.350, and Part 803.” 05/28/2019

Comments Extended on Device Inspection Standards
Federal Register notice: FDA extends the comment period on a draft guidance entitled “Review and Update of Device Establishment Inspection Processes and Standards.” 05/28/2019

Regulatory Review Period for Edwards Aortic Valve
Federal Register notice: FDA determines that the regulatory review period for Edwards Lifesciences’ Edwards Intuity Elite Aortic Valve is 1,508 days. 05/24/2019

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