FDA Policy/General

Latest Federal Register Notices

FDA Seeks Comments on Covid Guidances
1/21/2022 Federal Register notice: FDA is announcing recent guidance documents related to the Covid-19 public health emergency. Under emergency procedures, the documents have been implemented without prior comment, but they remain subject to comment in accordance with the agency’s good guidance practices. To view the notice, click here.

Draft Guide on 702(b) FDA Samples
1/21/2022 Federal Register notice: FDA is making available a draft guidance entitled Collecting and Providing 702(b) Portions of FDA Official Samples — Questions and Answers. Under Section 702(b) of the FD&C Act, when FDA collects a sample of a food, drug, or cosmetic for analysis, FDA must, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent. To view the notice, click here.

FDA Revokes 5 Covid Test EUAs
1/21/2022 Federal Register notice: FDA is announcing the revocation of the Emergency Use Authorizations (EUAs) issued to Cellex Inc. for the Cellex q–SARS–CoV–2 IgG/IgMRapid Test, BioMerieux SA for the SARS–COV–2 R–GENE, Siemens Healthcare Diagnostics Inc. for the Atellica IM SARS–CoV–2 IgG (COV2G), Siemens Healthcare Diagnostics Inc. for the Advia Centaur SARS–CoV–2 IgG, and Cepheid for the XpertOmni SARS–CoV–2. FDA revoked the EUAs after the companies notified it that the tests were no longer marketed, distributed or supported and requested they be revoked. To view the notice, click here.

Proposal to Classify Certain Antigen Devices in Class 2
1/20/2022 Federal Register notice: FDA is seeking comments on its proposal to classify human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices into Class 2 (special controls). The agency says it does not intend to exempt these device types from premarket notification requirements. After considering comments, FDA will publish a final regulation classifying the device types. To view the notice, click here.

FDA Corrects Notice on ANDA Withdrawal
1/18/2022 Federal Register notice: FDA is correcting a 10/22/2021 notice that announced the withdrawal of 216 ANDAs. The document was published with an incorrect date, and it wrongly indicated that Bio-Nucleonics’ ANDA 075941 for strontium chloride SR–89 injection was being withdrawn. 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