FDA Policy/General

Latest Federal Register Notices

Docket No. Corrected on Dietary Supplement Notice
Federal Register notice: FDA corrects the docket number in a 9/7 Federal Register notice announcing a draft guidance entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.” 10/05/2018

Info Collection Extension Sought for User Fee Forms
Federal Register notice: FDA submits to OMB an information collection extension for “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914.” 10/05/2018

Joint Panel to Review ‘Abuse-deterrent’ Pain Drug
Federal Register notice: FDA announces an 11/14 joint advisory committee meeting to discuss a SpecGx NDA for its abuse-deterrent pain drug. 10/05/2018

Comments Extended on Guide for Export Certificates
Federal Register notice: FDA extends the comment period for a draft guidance entitled “Process To Request a Review of FDA’s Decision Not To Issue Certain Export Certificates for Devices.” 10/04/2018

Comments Sought on Info Collection for INDs
Federal Register notice: FDA seeks comments on an information collection extension entitled “Investigational New Drug Application—21 CFR Part 312.” 10/04/2018

CDRH Lists Guidance Docs for FY 2019
Federal Register notice: FDA has announced the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal year 2019. 10/04/2018

FDA, Canada Public Meeting on ICH Activities
Federal Register notice: FDA announces a 10/17 regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.” 10/04/2018

Guide on Drug Packaging and Labeling Terms
Federal Register notice: FDA makes available a final guidance entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.” 10/03/2018

Draft Guide on ANDA Blocking Petitions
Federal Register notice: FDA makes available a draft guidance entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” 10/03/2018

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