…OTC sale. Following this, in June 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) made a similar recommendation of creating a new category of OTC “wearable hearing devices.”…

…the ”regulation does not, therefore, preempt state law . . . .” Similarly, the Court stated, “FDA’s silence regarding acetaminophen-specific warning does not preempt state law.” Thus, the Court presumed,…

…far, this pronouncement. If FDA is serious about making access to OTC home diagnostics a priority, it needs to provide clear, comprehensible, specific, and reasonable guidance to industry about the…

…FY 2022, at 13-18, https://www.fda.gov/media/167825/download?attachment. [14] FDA, 510(k) Premarket Notification Search Database (last updated Nov. 13, 2023), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Searches were done for all IVD panels: immunology, microbiology, clinical chemistry, pathology,…

…hearing aids, as defined under section 520(q) of the Federal Food, Drug, and Cosmetic Act, through in-person transactions, by mail, or online.” While some comments, including those from 41 State…

…medicine containing pseudoephedrine, which, under the Combat Methamphetamine Epidemic Act of 2005, is limited to Behind-the-Counter (“BTC”) sales. Previous explorations to create a third category of drugs have petered out. …

…and require that any beef product labeled as “Made in the USA,” “Product of the USA,” “USA beef,” or otherwise indicated to be U.S. beef, come from cattle that have…

…the request.  He cited FDA’s previous decision not to commence such proceedings despite “eating up eleven months, 47,000 public comments, and hundreds of thousands, if not millions, of dollars” in…

…of simultaneous prescription and OTC marketing of the same drug.  As we previously discussed, FDA has relied on FDC Act § 503(b), generally, to assert that, absent a “meaningful difference,”…

…323.1 (listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America). However, this list is not exhaustive. The final rule does not supersede, alter, or…

…or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support,…

…Certuss-D, and Trexbrom, FDA’s Warning Letter states:  Certuss, Certuss-D, and Trexbrom contain the active ingredient chlophedianol, which is an acceptable antitussive active ingredient.  However, chlophedianol cannot be combined with the…

…for concerns about marketing, pediatric use of hearing aids, return policies, and gain limits. FDA seemingly dismissed most of these concerns, and, the Report notes, “[a]s of February 2024, FDA…

As we previously reported, the Made in the USA claim, as a voluntary claim on consumer goods, including products under FDA jurisdiction such as foods, over-the-counter drugs, and cosmetics, continues…

…argued, among other things, that even if rulemaking is appropriate, FDA cannot use informal notice-and-comment rulemaking, but instead must use formal, hearing-based rulemaking.   Forced switch proponents have argued, among other…