FDA Policy/General

Latest Federal Register Notices

FDA Panel To Review Cordis PMA Adverse Events
Federal Register notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee reviews a Cordis PMA for the Incraft AAA Stent Graft System. 05/11/2018

Guide on Outsourcing Facility Definition
Federal Register notice: FDA makes available a guidance entitled “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” 05/11/2018

Comments Sought on Biologic Samples Requests
Federal Register notice: FDA seeks comments on an information collection extension for “Request for Samples and Protocols” (OMB Control Number 0910–0206). 05/11/2018

FDA Determines ANDA Eligibility for Sodium Iodide
Federal Register notice: FDA determines that GE Healthcare’s sodium iodide I 123 oral solution, 2 millicuries/milliliter was not withdrawn from sale due to safety or effectiveness. 05/11/2018

Guide on Toxicokinetics Q & A
Federal Register notice. FDA makes available a guidance entitled “S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling — Questions and Answers.” 05/10/2018

Draft Guide on Urinary Tract Infections
Federal Register notice: FDA makes available a draft guidance entitled “Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.” 05/10/2018

Comments Sought on Therapeutic Protein Drug-Drug Interactions
Federal Register notice: FDA establishes a public docket to assist with its development of a policy/guidance document on assessing drug-drug interactions for therapeutic proteins. 05/09/2018

Draft Guide on Sec. 582 Waivers, Exceptions
Federal Register notice: FDA makes available a draft guidance entitled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.” 05/09/2018

Heart Questionnaire Qualified for Device Developers
Federal Register notice: FDA qualifies the Minnesota Living with Heart Failure Questionnaire from the University of Minnesota as part of its Medical Device Development Tools program. 05/07/2018

FDA Corrects Docket Number on OMB Approval Notice
Federal Register notice: FDA is correcting a 4/9 Federal Register notice about OMB approval of several information collection activities. 05/07/2018

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

Read more

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