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…customers. As far as we know, there are no definitive data on the volume of OTC sales. According to HIA, OTC hearing aid sales are estimated from 100,000 to one…
…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,…
FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. The first OTC IVD cleared by FDA was a…
…. . . The FDC Act was amended in 1951 by the Durham-Humphrey Amendment, Pub. L. No. 82-215, 65 Stat. 648 (1951), to give FDA the authority to require that…
…Quality, Certification and Oversight Reports (QCOR), Active CLIA Laboratory Search Database, https://qcor.cms.gov/advanced_find_provider.jsp?which=4&backReport=active_CLIA.jsp. [4] PRIA at 28. [5] Id. at 75. [6] 88 Fed. Reg. 68006, 68012 (Oct. 3. 2023) (hereinafter…
…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….
…FDA Commissioner Dr. Margaret Hamburg announced that the Agency’s decision had been overruled by Ms. Sebelius. (See our previous post here.) In a highly unusual and surprisingly public move, Ms….
…PLAN B One-Step situation . . . . If FDA has, in fact, granted (or will grant) 3-year exclusivity vis-à-vis the change approved in the April 30th supplement (i.e., OTC…
…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…
…180-day, real-time or panel track supplement to FDA; and For Health Canada, specify if it represents a new or significant change amendment Class III or IV submission to Health Canada….
…[(53 Fed. Reg. 30,522, 30,554 (Aug. 12, 1988))] . . . and The agency believes that an OTC drug product containing diphenhydramine citrate or diphenhydramine hydrochloride that is labeled both…
…FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status. All 19 members of the joint Advisory Committee agreed that the benefit-risk profile of Narcan Nasal…
…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…
…product no longer can be marketed lawfully following the OTC switch. See, e.g., Breckenridge Pharms., Inc. v. FDA, 754 Fed. Appx. 1, 3 (D.C. Cir. 2018) (citing 21 U.S.C. §…
…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…