FDA Policy/General

Latest Federal Register Notices

Workshop on Nontuberculous Mycobacterial Disease Drugs
Federal Register notice: FDA announces a 4/8 public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” 03/22/2019

Antimicrobial Drugs Advisory Committee Meeting on Bacitracin
Federal Register notice: FDA announces a 4/26 Antimicrobial Drugs Advisory Committee meeting to discuss the safety and effectiveness of bacitracin for intramuscular injection for treating infants with pneumonia and empyema caused by staphylococci. 03/22/2019

Guide on Pediatric HIV Drug Development
Federal Register notice: FDA makes available a final guidance entitled “Pediatric HIV Infection: Drug Product Development for Treatment.” 03/20/2019

Guide on Pre-Exposure HIV Drug Development
Federal Register notice: FDA makes available a final guidance entitled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.” 03/20/2019

Info Collection on Device Symbols in Labeling
Federal Register notice: FDA seeks comments on an information collection extension for “Medical Devices: Use of Symbols in Labeling — Glossary to Support the Use of Symbols in Labeling.” 03/18/2019

Clinical Trial Enrichment Strategies Guide
Federal Register notice: FDA makes available a final guidance entitled “Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.” 03/15/2019

Guide on Hematologic Disorders Drug Development
Federal Register notice: FDA makes available a final guidance entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” 03/15/2019

Draft Guide on Clinical Trial Sponsor Monitoring
Federal Register notice: FDA makes available a draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” 03/15/2019

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