FDA Policy/General

Latest Federal Register Notices

Guide on Nanomaterial in Drugs/Biologics
04/22/2022 Federal Register notice: FDA has made available a final guidance entitled Drug Products, Including Biological Products, That Contain Nanomaterials. The document provides the agency’s current thinking on developing products that contain a nanomaterial in the finished dosage form. To view the notice, click here.

Guidance on N-Acetyl-L-Cysteine Policy
04/22/2022 Federal Register notice: FDA has made available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine. The document explains the agency’s intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine and are labeled as dietary supplements. To view the notice, click here.

Covid-19 Vaccine Guidance Update
04/22/2022 Federal Register notice: FDA is announcing the availability of an updated guidance entitled Emergency Use Authorization for Vaccines to Prevent Covid–19 (Updated 3/31). The document has been implemented without prior comment, but it remains subject to comment under the agency’s good guidance practices. To view the notice, click here.

Docket Established for Opioid Disposal
04/21/2022 Federal Register notice: FDA has established a docket to solicit public comments on a potential modification to its Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that mail-back envelopes be dispensed along with education on safe disposal provided with opioid analgesics dispensed in an outpatient setting. To view the notice, click here.

Modifications to Device Recognized Standards
04/21/2022 Federal Register notice: FDA is announcing modifications to its list of standards the agency recognizes for use in premarket reviews. “Modifications to the List of Recognized Standards, Recognition List Number: 057” 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.

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