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Do You Hear What I Hear? One Year of OTC Hearing Aids
…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…
FDA-Approved Labeling: Is Enough Enough?
…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,…
Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests
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…
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
…. . . 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…
A Final LDT Rule in April!? Will FDA be Prepared?
…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…
Papa Can You Hear Me? Now You Can Thanks to OTC Hearing Aids
…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….
Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”
…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….
FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
…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…
‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules
…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…
FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests
…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….
An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions
…[(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…
Is 2023 the Year for OTC Naloxone?
…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…
Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?
…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…
In Bid to Curtail 180-day Exclusivity, FDA Alters Longstanding Practice and Newly Declares that Converted OTC Products Are Not “Listed Drugs”
…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. §…
OTC Hearing Aids: “Nothing to See Here” Says GAO Report
…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…