FDA Policy/General

Latest Federal Register Notices

FDA Implementing Fallout from Drug/Device Case
8/13/2021 Federal Register notice: FDA has announced its implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA. The 4/16 decision affirmed a district court ruling that FDA is not afforded discretion when a combination product meets the definition of both a device and a drug. The notice provides information for stakeholders and solicits public comment to inform the agency’s deliberations about products potentially impacted by the Genus decision and the way in which impacted products should be transitioned from drug to device status. For example, implementation will require FDA to transition some approved products from drug status to device status. To view the notice, click here.

MOU Period Extended for Compounded Drugs
8/13/2021 Federal Register notice: FDA is extending the period for states to decide whether to sign the final standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S. Food and Drug Administration” before the agency intends to begin enforcing the statutory 5% limit on distribution of compounded human drug products out of the state in which they are compounded in states that do not sign the final standard MOU. The period was scheduled to end on 10/27 and now is extended until 10/27/2022. To view the notice, click here.

Covid EUA Listing Updated
8/11/2021 Federal Register notice: FDA is updating its listing of Emergency Use Authorizations (EUAs) for use during the Covid-19 pandemic. It has been updated to reflect a 5/26 EUA for GlaxoSmithKline’s sotrovimab, and a 6/24 EUA for Genentech’s Actemra (tocilizumab). To view the notice, click here.

Votrient Not Withdrawn Due to Safety/Efficacy: FDA
8/11/2021 Federal Register notice: FDA has determined that Novartis’ Votrient (pazopanib hydrochloride) tablets, 400 mg, were not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Votrient is a kinase inhibitor indicated for treating patients with advanced renal cell carcinoma. To view the notice, click here.

Info Collection on Device Recall Authority
8/10/2021 Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Recall Authority--21 CFR Part 810” (Control Number 0910-0432). Section 518(e) of the Federal Food, Drug, and Cosmetic Act provides FDA with the authority in certain instances to issue an order requiring companies to: (1) immediately cease distribution of such device and (2) immediately notify health professionals and device-user facilities of the order and to instruct such professionals and facilities to cease use of such device. 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

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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