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…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…
…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. …
…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,”…
…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…
…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…
…context of over-the-counter (“OTC”) conversions. By way of background, FDA’s longstanding regulations “fulfill[] the statutory requirements for patent listing,” 80 Fed. Reg. 6,802, 6,823, by compelling NDA holders to submit…
…been redesigned, but the redesign has not been studied in another HFVS. However, in reaching their unanimous decision, committee members emphasized that (1) naloxone is effective in treating opioid overdoses,…
…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…
Since March 2020 when the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law establishing section 505G of the Food, Drug, and Cosmetic Act (FD&C Act)…
…(“OTC”) use of Nasacort Allergy 24 HR (“OTC NASACORT”) for the temporary relief of symptoms of hay fever or other respiratory allergies (nasal congestion, runny nose, sneezing, and itchy nose)…