FDA Policy/General

Latest Federal Register Notices

Sunscreen OTC Monograph Proposed Order Available
9/24/2021 Federal Register notice: FDA has made availability of an over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled “Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.” The order would amend and revise an administrative order concerning nonprescription sunscreen drug products established by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The proposed order, if finalized, would offer new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective under the Federal Food, Drug, and Cosmetic Act. To view the notice, click here.

FDA Revokes 3 EUAs for No-longer-marketed Tests
9/24/2021 Federal Register notice: FDA has announced it is revoking the emergency use authorizations issued to Gravity Diagnostics for the Gravity Diagnostics Covid–19 Assay, Materials and Machines Corporation of America for the MatMaCorp Covid–19 2SF Test, and Guardant Health for the Guardant-19. The revocations are based on company requests because the tests are no longer being marketed/distributed. To view the notice, click here.

Advisory Panel to Discuss Reata Pharma NDA
9/23/2021 Federal Register notice: FDA has announced a 12/8 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Reata Pharmaceuticals NDA for its Nrf2 activator bardoxolone methyl capsules, indicated for slowing chronic kidney disease progression caused by Alport syndrome in patients 12 years of age and older. To view the notice, click here.

Guide on GMPs for Animal Cell, Tissue Products
9/22/2021 Federal Register notice: FDA has made available a draft guidance for industry #253 entitled Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products. The document is intended to provide establishments that manufacture animal cells, tissues, and cell- and tissue-based products (ACTPs) with recommendations for meeting requirements for current good manufacturing practices (CGMPs). It also addresses the methods, facilities, and controls used for manufacturing ACTPs. To view the notice, click here.

Public Meeting on Biosimilar User Fee Reauthorization
9/21/2021 Federal Register notice: FDA has announced an 11/2 virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act for fiscal years 2023 through 2027. 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