FDA Policy/General

Latest Federal Register Notices

Ortho-Cept Not Withdrawn Due to Safety/Efficacy: FDA8/20/2021 Federal Register notice: FDA has determined that Janssen Pharmaceuticals Ortho-Cept (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to withdraw ANDAs that reference the drug product, and it will allow the agency to continue to approve related ANDAs if they meet relevant legal and regulatory requirements. Ortho-Cept is indicated for preventing pregnancy. To view the notice, click here.

Info Collection on Drug Compounding
8/20/2021 Federal Register notice: FDA has submitted to OMB 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 revision pertains to guidance documents issued in 2017 and 2018 to assist compounders. To view the notice, click here.

Comments Extended for Drug Scheduling Notice
8/16/2021 Federal Register notice: FDA is reopening the comment period for a 7/23 notice entitled “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F– MDMB–BICA (4F–MDMB–BUTICA); Brorphine; Metonitazene; Eutylone (bk- EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut.” The comments will be considered in preparing a response from the U.S. to the World Health Organization regarding the abuse liability and diversion of these drugs. WHO will use the information to consider whether to recommend that certain international restrictions be placed on these drug substances. Comments are now being accepted until 8/24. 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