FDA Policy/General

Latest Federal Register Notices

Assessment of Quantitative Imaging Devices Guide
Federal Register notice: FDA makes available a draft guidance entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” 04/19/2019

Draft Guide on Nitinol-Containing Medical Devices
Federal Register notice: FDA announces the availability of a draft guidance entitled “Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.” 04/19/2019

Guide on Bispecific Antibody Development Programs
Federal Register notice: FDA makes available a draft guidance entitled “Bispecific Antibody Development Programs.” 04/19/2019

Comments Extended for Sunscreen Proposed Rule
Federal Register notice: FDA extends the comment period for a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products. 04/18/2019

Proposed Rule on Sunscreens Corrected
Federal Register notice: FDA corrects a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products. 04/18/2019

Info Collection Extension for Animal ANDAs
Federal Register notice: FDA seeks comments on an information collection extension for “Abbreviated New Animal Drug Applications — Sections 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1)).” 04/18/2019

Trisenox Not Withdrawn Over Safety/Efficacy: FDA
Federal Register notice: FDA determines that Cephalon’s Trisenox (arsenic trioxide) injection, 1mg/mL, was not withdrawn for safety or effectiveness reasons. 04/18/2019

Info Collection Extension for Expanded Access Requests
Federal Register notice: FDA submits to OMB an information collection extension for its “Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926.” 04/17/2019

Info Collection Extension for CVM E-submissions
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance for Industry on Registering with the Center for Veterinary Medicine’s Electronic Submission System — 21 CFR 11.2” 04/16/2019

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