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Do You Hear What I Hear? One Year of OTC Hearing Aids
…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…
FDA-Approved Labeling: Is Enough Enough?
…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…
Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests
…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,…
A Final LDT Rule in April!? Will FDA be Prepared?
…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…
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
…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…
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….
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) 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…
An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions
…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…
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,…
DEA Administrative Decisions Update: Sex, Drugs, and . . . Rocky Agency Precedent
…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:…
‘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…
Nevada State Court Judge Says There’s a Hole in Mensing Preemption for Some “Dear Doctor” Letters
…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…
In Bid to Curtail 180-day Exclusivity, FDA Alters Longstanding Practice and Newly Declares that Converted OTC Products Are Not “Listed Drugs”
…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…
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…
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…