FDA Policy/General

Latest Federal Register Notices

Pediatric Panels to Review Duchenne Trial Protocol 05/02/2017
Federal Register notice: FDA announces a 5/18 joint Pediatric Advisory Committee and Pediatric Ethics Subcommittee meeting to discuss a referral by an Institutional Review Board of a clinical investigation that involves children with Duchenne muscular dystrophy.

FDA Seeks Comments on GLP Recordkeeping 05/02/2017
Federal Register notice: FDA seeks comments on an information collection extension for “Good Laboratory Practice Regulations for Nonclinical Studies — 21 CFR Part 58 OMB Control Number 0910–0119.”

Comments Sought on Patent Term Restoration Petitions 05/02/2017
Federal Register notice: FDA seeks comments on an information collection extension on “Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions — 21 CFR Part 60 — OMB Control Number 0910–0233.”

Conference for Small Business Industry Assistance 05/03/2017
Federal Register notice: CDER and CDRH announce a two-day (5/9-10) public conference entitled “FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Spring Conference.”

Workshop on Sentinel Queries 05/03/2017
Federal Register notice: FDA announces a 7/10 public workshop entitled “Sentinel Training at FDA.”

Marathon Granted Priority Review Voucher 05/03/2017
Federal Register notice: FDA issues a priority review voucher to Marathon Pharmaceuticals for its recently approved Emflaza (deflazacort) tablets and oral suspension for treating patients age five and older with Duchenne muscular dystrophy.

Comments Sought on Ampicillin Pediatric Data Report 05/03/2017
Federal Register notice: FDA seeks comments on a report evaluating pediatric studies of ampicillin.

Comments Sought on New ID Form for FOI Requests 05/04/2017
Federal Register notice: FDA seeks comments on a new information collection on “Certification of Identity for Freedom of Information Act (FOIA) and Privacy Act Requests — OMB Control Number 0910.”

FDA Co-hosting Workshop on Device Cybersecurity 05/04/2017
Federal Register notice: FDA, the National Science Foundation and Department of Homeland Security, Science and Technology announce a public workshop entitled “Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis.”

Comments Sought on Extending Citizen Petition Guidance 05/04/2017
Federal Register notice: FDA seeks comments on an information collection extension for “Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.”

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