FDA Policy/General

Info Collection on OTC Drugs

Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Time and Extent Applications (TEA) for Nonprescription Drug Products.” The agency says the Coronavirus Aid, Relief, and Economic Security Act included provisions on the way certain OTC drugs are regulated, such as adding section 505G to the Federal Food, Drug, and Cosmetic Act that reforms and modernizes the OTC review process, such as new procedures for considering additions or changes to conditions covered in OTC monographs. Because of this, FDA is expecting no submissions under Section 330.14, which establishes additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded. Additionally, 505G(k)(3) allows the agency to withdraw the regulations supporting the TEA provisions in part 330 and discontinue the related guidance document. When these actions occur, FDA says it will also request discontinuation of the related information collection. 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’

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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

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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