FDA Policy/General

Latest Federal Register Notices

Drug User Fee Notice Correction
3/25/2022 Federal Register notice: FDA is correcting an 8/16/2021 notice entitled “Prescription Drug User Fee Rates for Fiscal Year 2022.” The notice was published with errors, which do not have an impact on the previously published user fee rates but are corrected in this notice for clarity. To view the notice, click here.

FDA Withdraws Farydak Over Confirmatory Study
3/24/2022 Federal Register notice: FDA is withdrawing approval of a Secura Bio NDA for Farydak (panobinostat) capsules after the company requested the action. The company said the accelerated-approval drug, which is used in treating multiple myeloma, was not shown to be effective in a confirmatory postmarketing study because it was not feasible for them to complete the required trial. To view the notice, click here.

Obstetrics, Reproductive Drugs Panel Renewed
3/23/2022 Federal Register notice: FDA has renewed its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until the 3/23/2024. To view the notice, click here.

Guide on Ophthalmic Drugs Compliance Policy
3/23/2022 Federal Register notice: FDA has made available a final guidance entitled “Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4.” The document describes FDA’s compliance policy regarding requirements that are now applicable to ophthalmic drugs packaged with eye cups, eye droppers, and other dispensers intended for ophthalmic use. To view the notice, click here.

Vaccines Panel to Discuss Covid-19 Boosters
3/22/2022 Federal Register notice: FDA has announced a 4/6 Vaccines and Related Biological Products Advisory Committee meeting to discuss considerations for use of Covid–19 vaccine booster doses and the process for Covid–19 vaccine strain selection to address current and emerging variants. 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