FDA Policy/General

Latest Federal Register Notices

Draft Guide on Drug Supply Trading Partners
Federal Register notice: FDA makes available a draft guidance entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act.” 08/25/2017

Guidance on Oncology Drugs for Companion Animals
Federal Register notice: FDA makes available a guidance for industry #237 entitled “Oncology Drugs for Companion Animals.” 08/25/2017

Comments Sought on eSubmissions for CDRH Product Complaints
Federal Register notice: FDA seeks comments on an information collection entitled “Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health — OMB Control Number 0910–0769.” 08/24/2017

Comments Sought on OTC Drugs Under GRASE
Federal Register notice: FDA seeks comments on an information collection related to “Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded — 21 CFR 330.14.” 08/23/2017

Advisory Committee to Review PTC Therapeutics NDA
Federal Register notice: FDA announces a 9/28 Peripheral and Central Nervous System Drugs Advisory Committee meeting to review a PTC Therapeutics NDA for ataluren. 08/23/2017

Comments Sought on Informed Consent Exception for Diagnostics
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices; Exception From General Requirements for Informed Consent.” 08/22/2017

Pediatric Advisory Committee to Conduct Safety Reviews
Federal Register notice: FDA announces a 9/11-12 Pediatric Advisory Committee meeting in Rockville, MD to conduct pediatric-focused safety reviews. 08/22/2017

Docket Established for DTC Risk Info Recommendations
Federal Register notice: FDA establishes a public docket to assist with its development of recommendations on the communication of risk information in direct-to-consumer broadcast ads. 08/22/2017

CDRH Mailing Address Change for Device Classifications
Federal Register final rule technical amendment: FDA is amending the Medical Device Classification Procedures regulation to reflect a change in address for CDRH. 08/22/2017

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