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…OTC hearing aids in their stores or on their websites, and some are available at audiology clinics. And the number of companies selling OTC hearing aids is impressive: as of…
…an OTC monograph, which basically serves as an instruction manual for making and labeling certain OTC drugs. Relevant to our conversation, OTC monographs establish conditions—such as active ingredients and indications…
…Though there has been a large number of OTC IVD clearances and decades of experience reviewing OTC IVDs, the bulk of OTC IVD clearances fall in just a few categories,…
…https://www.mddionline.com/news/510k-statistical-patterns. [12] FDA, Third Party Review Organization Performance Report (version 1 of FY2022, Q4), at 38, https://www.fda.gov/media/162658/download?attachment [13] See id.; FDA, Performance Report to Congress: Medical Device User Fee Amendments…
…for OTC use in certain women. Historically, a “meaningful difference” exists if the Rx and OTC drug products differ in: (1) active ingredient; (2) indication; (3) strength; (4) route of…
…especially a concern in the context of self-fitting hearing aids. As the Proposed Rule suggested, self-fitting hearing aids are OTC hearing aids, but not all OTC hearing aids are self-fitting….
…PLAN B One-Step) available Over-the-Counter (“OTC”) and without point-of-sale or age restrictions (see our previous post here). (Judge Korman recently clarified that the 30-day deadline for compliance with his order…
…directions for the combination product may not exceed any maximum dosage limits established for the individual ingredients in the applicable OTC drug monograph. Similar statements appear in other OTC drug…
…submitted to FDA and Health Canada within 6 months of acceptance of the pilot program: For FDA, specify if it is a 510(k), De Novo, or pre-market approval (PMA) original,…
…doctor’s application. In the lengthy final order, the Administrator took issue with several of the legal issues addressed by the CALJ, including the following. Interpretation of Oklahoma Medical Board Standards:…
…it did eventually issue proposed rules establishing OTC hearing aids in October 2021, after President Biden issued an Executive Order in July 2021 commanding publication. The Comment Period for those…
…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…
…concluded that Mensing does not preempt the Plaintiffs’ claims that certain generic drug manufacturers could have sent a “Dear Doctor” or “Dear Healthcare Provider” letter warning against reuse of vials…
…anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent GAO Report hasn’t found that OTC hearing aids have had much impact. While that’s not…
…state that you are requesting FDA initiate notice-and-comment rulemaking, the Act . . . authorizes only two mechanisms for FDA to make an Rx to OTC switch: [informal] notice-and-comment rulemaking…