FDA Policy/General

Latest Federal Register Notices

Draft Guide on Generic Rifaximin Bioequivalence 03/17/2017
Federal Register notice: FDA makes available a revised draft guidance for industry on generic rifaximin oral tablets and bioequivalence issues.

FDA Eliminates Regional Director Positions 03/17/2017
Federal Register final rule technical amendment: FDA makes revisions to Chapter I of its regulations to eliminate the position of regional food and drug director.

Comments Sought on Pharmacogenomic Data Submissions 03/17/2017
Federal Register Notice: FDA seeks comments on an information collection extension for its “Guidance for Industry on Pharmacogenomic Data Submissions.”

Comments Sought on 510(k) Cover Sheet 03/17/2017
Federal Register Notice: FDA seeks comments on an information collection reinstatement for “Premarket Notification—21 CFR Part 807, Subpart E.

Comments Sought on Device Pediatric Use Information 03/17/2017
Federal Register Notice: FDA seeks comments on an information collection extension for its guidance on “Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.”

Cyanocobalamin Not Withdraw Over Safety/Effectiveness 03/16/2017
Federal Register notice: FDA determines that cyanocobalamin injection, 1 milligram per milliliter in a 10 milliliter vial, was not withdrawn for reasons related to safety or effectiveness.

Sarcopenia Meeting Location Changed 03/16/2017
Federal Register notice: FDA corrects a 12/15/2016 notice entitled “Public Meeting on Patient-Focused Drug Development for Sarcopenia” to reflect a change in meeting location.

FDA Posts 10 OMB Comment Request Notices 03/15/2017
Federal Register: FDA posts ten Office of Management and Budget information collection notices that have been backlogged and now released after a regulatory review by the Trump administration.

Glucose Monitor Display Put Into Class 2 03/15/2017
Federal Register Final Order: FDA classifies as a Class 2 (special controls) medical device the continuous glucose monitor secondary display.

Genomic Sequence Analyzer Put Into Class 2 03/15/2017
Federal Register Final Order: FDA classifies as a Class 2 (special controls) medical device the high throughput genomic sequence analyzer for clinical use.

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