FDA Policy/General

Latest Federal Register Notices

Guide on Anthrax Prevention Drugs
Federal Register notice: FDA makes available a guidance entitled ‘‘Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.’’ 05/24/2018

Comments Sought on Study Design for Heartworm Drugs
Federal Register notice: FDA seeks comments as it evaluates current thinking about the design of studies intended to generate data to support investigational new animal drugs intended for preventing heartworm disease in dogs. 05/24/2018

Info Collection Extension for PDMA Policies, Requirements
Federal Register notice: FDA submits to OMB for approval an information collection extension for “Prescription Drug Marketing Act of 1987 — Administrative Procedures, Policies, and Requirements” (OMB Control Number 0910–0435). 05/24/2018

Guide on OTC Sunscreen Enforcement Policy
Federal Register notice: FDA makes available a guidance entitled “Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application.” 05/23/2018

Guide on OTC Maximal Usage Drug Trials
Federal Register notice: FDA makes available a draft guidance for industry entitled “Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” 05/23/2018

Panel to Review Opioid NDA with Abuse-deterrent Properties
Federal Register notice: FDA announces a 6/26 joint advisory committee meeting to review a Pain Therapeutics NDA for a proposed abuse-deterrent oxycodone extended-release capsule. 05/23/2018

Guidance on OTC Sunscreen Product Enforcement Policy
Federal Register notice: FDA posts a guidance on “Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application.” 05/22/2018

Comments Sought on ANDA Controlled Correspondence
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.” 5/22/2018

Comments Sought on pH-dependent Drug-Drug Interactions
Federal Register notice: FDA establishes a public docket to assist with developing a policy or guidance document on assessing pH-dependent drug-drug interactions. 05/22/2018

Guide on Bioanalytical Method Validation
Federal Register notice: FDA makes available a guidance entitled “Bioanalytical Method Validation.”05/22/2018

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