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Do You Hear What I Hear? One Year of OTC Hearing Aids
…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.”…
FDA Issues Proposed Order to Facilitate Minor Changes to Solid Oral Dosage Forms to OTC Monograph Drugs, but Such Changes May Come at a Price
…Comments to proposed order OTC0000037 must be submitted by August 4, 2025, and comments to proposed order OTC0000038 and the accompanying draft guidance must be submitted by October 3, 2025….
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,…
An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions
…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…
FDA Petition Response Reaffirms FDA Orange Book Dosage Form Nomenclature Policy
…regulations at 21 C.F.R. §§ 314.3(b) and 320.1(b), however, include the term “dosage form” in the definition of “drug product:” “[A] finished dosage form, for example, tablet, capsule, or solution,…
Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests
…not grant marketing authorization of an OTC COVID test until June 6, 2023, when Cue Health finally received de novo authorization. Most recently, Jeff Shuren, CDRH Director, gave a speech…
A Final LDT Rule in April!? Will FDA be Prepared?
…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,…
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…
Papa Can You Hear Me? Now You Can Thanks to OTC Hearing Aids
…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…
FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
…remedy Judge Korman ordered is erroneous for (at least) two reasons: First, the Court exceeded its authority by issuing an order concerning the “one-pill product,” i.e., Plan B One-Step (PBOS),…
FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests
…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,…
Sunscreen’s Moment to Shine: FDA Announces a Flurry of New Requirements for OTC Sunscreen Drug Products
…dosage forms is pending, FDA will permit spray dosage forms to be marketed. However, FDA may take regulatory action against products such as wipes, towelettes, powders, body washes, and shampoos. …
Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?
…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…
‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules
…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,…
OTC Hearing Aids: “Nothing to See Here” Says GAO Report
…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…