FDA Policy/General

Latest Federal Register Notices

Regulatory Review Period Determined for Impella 2.5 System
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Abiomed Europe’s Impella 2.5 System. 10/06/2017

Regulatory Review Period Determined for Bayer’s Kovaltry
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Bayer’s Kovaltry (antihemophilic factor (recombinant)). 10/06/2017

FDA/Canada Joint Public Meeting on ICH Preparation
Federal Register notice: FDA announces a 10/19 regional public meeting entitled “Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” 10/05/2017

Science Advisory Board Meeting Announced
Federal Register notice: FDA announces an 11/6-7 Science Advisory Board to the National Center for Toxicological Research meeting. 10/05/2017

Comments Sought on Pregnancy Labeling Requirements
Federal Register notice: FDA requests comments on an information collection extension for “Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling.” 10/04/2017

Patient Engagement Advisory Committee Meeting Amendments
Federal Register notice: FDA announces amendments to an earlier notice that provided details of a 10/11-12 Patient Engagement Advisory Committee meeting. 10/04/2017

Joint FDA Panel to Review Braeburn Pharmaceuticals Drug
Federal Register notice: An FDA advisory committee reviews a Braeburn Pharmaceuticals NDA for buprenorphine subcutaneous injection and its use for treating opioid dependence. 10/03/2017

Joint Panel to Mull Opioid Dependence NDA
Federal Register notice: FDA joint advisory committee meeting reviews Indivior Pharmaceuticals NDA for buprenorphine subcutaneous injection and its use in treating opioid dependence. 10/03/2017

Comments Sought on REMS Standards Initiative
Federal Register notice: FDA seeks public input on the design of its REMS Platform Standards Initiative, as well as methods and best practices. 10/03/2017

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

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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