FDA Policy/General

Latest Federal Register Notices

Patrick Bishop Debarred for 5 Years
3/4/2022 Federal Register notice: FDA has issued an order to debar Patrick Charles Bishop for a period of five years from importing or offering for import any drug into the U.S. The agency based its action on Bishop’s felony conviction for importing an unapproved drug. To view the notice, click here.

Guide on Timely Product Recalls
3/4/2022 Federal Register notice: FDA is making available a final guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.” The document provides input on timely initiation of voluntary recalls of FDA-regulated products. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. To view the notice, click here.

FDA Debars George Kuiper for 5 Years
3/3/2022 Federal Register notice: FDA is issuing an order to debar George Kuiper for a period of five years from importing or offering for import any drug into the U.S. The order is based on a finding that Kuiper was convicted of multiple felony offenses: One count of smuggling, one count of conspiracy to smuggle goods into the U.S. and to introduce into interstate commerce unapproved drugs, and one count of introduction into interstate commerce of unapproved drugs. To view the notice, click here

Info Collection Extension on Emergency Use Authorization
3/3/2022 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Emergency Use Authorization of Medical Products” (OMB Control Number 0910-0595). The collection helps support implementation of agency policies applicable to authorizing medical products for use in emergencies under sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act. To view the notice, click here.

Guide on Older Adults in Cancer Trials
3/2/2022 Federal Register notice: FDA is making available a final guidance entitled “Inclusion of Older Adults in Cancer Clinical Trials.” The document provides recommendations about including older adult patients (aged 65 and older) in oncology drug clinical trials. It also emphasizes the importance of including adults over age 75 years in cancer clinical trials. To view the notice, click here.

Oncology Trial Master Protocols Guidance
3/2/2022 Federal Register notice: FDA is making available a final guidance entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” The document provides advice to sponsors about the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. The agency says master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple substudies, allowing for efficient and accelerated drug development. 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