FDA Policy/General

Latest Federal Register Notices

Covid Emergency Use Authorizations Listing Update
7/23/2021 Federal Register notice: FDA has updated its listing of emergency use authorizations granted during the Covid-19 public health emergency. Each listing contains, among other things, conditions on the product’s emergency use. To view the notice, click here.

Covid-19 Guidance Listing Updated
7/23/2021 Federal Register notice: FDA has updated its listing of guidance documents related to the Covid-19 public health emergency. The guidances 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.

Guide on Field Alert Reports
7/23/2021 Federal Register notice: FDA is making available a final guidance entitled Field Alert Report Submission: Questions and Answers. The document discusses the requirements for submission of field alert reports (FARs) by NDA and ANDA applicants, and it outlines recommendations for FAR submissions to help improve their consistency and relevancy. To view the notice, click here.

Medical Product Communications Info Collection
7/22/2021 Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers” (OMB Control Number 0910-0856). The collection supports agency guidance under the same title that includes recommendations that firms consider when developing “consistent with the FDA-required labeling (CFL)” presentations in their labeling and advertising materials to help ensure the presentations are not false or misleading. 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