FDA Policy/General

Latest Federal Register Notices

Guide on Epidermolysis Bullosa Drug Development
Federal Register notice: FDA makes available a final guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” 07/08/2019

Final Rule on CDRH Supervisory Review of Decisions
Federal Register notice: FDA issues a final rule to amend its regulations on internal agency supervisory review of certain decisions related to devices regulated by CDRH. 07/08/2019

Device GMP Advisory Committee Seeks Reps
Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee notify it in writing. 07/08/2019

Patient Engagement Panel to Review Device Cybersecurity
Federal Register notice: FDA announces a 9/10 Patient Engagement Advisory Committee meeting to discuss and make recommendations on “Cybersecurity in Medical Devices: Communication That Empowers Patients.” 07/08/2019

Comment Period Reopened on Drug Supply Chain
Federal Register notice: FDA reopens the comment period for the notices that published in the Federal Register of 4/15 and 4/28 regarding issues related to the drug supply chain. 07/08/2019

Docket Number Corrected on REMS Guidance
Federal Register notice: FDA corrects a 9/5/2017 notice entitled “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry.” 07/08/2019

Claforan Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that U.S. Pharmaceutical Holdings’ Claforan (cefotaxime sodium) for injection was not withdrawn from sale for reasons of safety or effectiveness. 07/08/2019

Workshop on Heart Failure Drug Endpoints
Federal Register notice: FDA announces a 7/26 public workshop entitled “Endpoints for Drug Development in Heart Failure.” 06/28/2019

Draft Guide on Heart Failure Drug Endpoints
Federal Register notice: FDA makes available a draft guidance entitled “Treatment for Heart Failure: Endpoints for Drug Development.” 06/28/2019

Proposed Rule on Biologic Master Files
Federal Register proposed rule: FDA proposes to amend its regulations concerning the use of master files for biological products. 06/28/2019

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