FDA Policy/General

Latest Federal Register Notices

Drug Product Communications Info Collection5/28/2021 Federal Register notice: FDA has announced that an information collection entitled ‘‘Data to Support Drug Product Communications’’ has been approved by OMB. To view the notice, click here.

Updated List of Device Consensus Standards5/28/2021 Federal Register notice: FDA is announcing a publication containing modifications to its list of standards FDA recognizes for use in premarket reviews. The publication, Modifications to the List of Recognized Standards, Recognition List Number: 055, is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view the notice, click here.

Info Collection on Drug Compounding5/27/2021 Federal Register notice: FDA is seeking comments on an information collection revision entitled “Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0858). The collection supports implementation of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, which govern compounding by pharmacies, outsourcing facilities, and other entities. To view the notice, click here.

Data Monitoring Committee Info Collection5/26/2021 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees” (OMB Control Number 0910-0581). The collection supports agency regulations and associated agency guidance requiring sponsors to monitor studies evaluating new drugs, biologics, and devices. To view the notice, click here.

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