FDA Policy/General

Latest Federal Register Notices

Draft Guide on Nicotine Replacement Drug Products
Federal Register notice: FDA makes available a draft guidance entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.” 02/22/2019

Rule on Bulk Drug Substances for Compounding
Federal Register notice: FDA issues a final rule to establish criteria for and identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Food, Drug, and Cosmetic Act. 02/20/2019

Class 2 for Titration Devices for Oral Appliances
Federal Register notice: FDA classifies auto titration devices for oral appliances into Class 2 (special controls). 02/20/2019

Nonbinding Feedback After Device Inspections Guide
Federal Register notice: FDA makes available a draft guidance entitled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments.” 02/19/2019

Guide on Expedited Programs for Regenerative Medicine Therapies
Federal Register notice: FDA posts a final guidance entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” 02/19/2019

Guide on Devices Used with Regenerative Medicine Therapies
Federal Register notice: FDA makes available a final guidance entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies” that provides the agency’s current thinking about how it intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products. 02/19/2019

Comments Reopened on Real World Evidence Program
Federal Register notice: FDA reopens the comment period on a 12/7/2018 notice entitled “Framework for a Real-World Evidence Program; Availability.” 02/15/2019

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