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Do You Hear What I Hear? One Year of OTC Hearing Aids
…this blog post, 54 companies list OTC hearing aids with FDA under the product code QUF while 18 companies list OTC self-fitting hearing aids under the product code QUH. However,…
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
By Kurt R. Karst – Every few years, interest in the creation of a third category of drug products – something other than prescription or Over-the-Counter (“OTC”) status – is…
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…
FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
…prescription and to those under age 17 with a prescription. Generic equivalents to Plan B are kept behind the pharmacy counter for the prescription product to be lawfully dispensed. What’s…
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…
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….
A Final LDT Rule in April!? Will FDA be Prepared?
…how many comments were actually logged in; on December 7, FDA showed 19,655 comments, and the next day 6,732.) While some comments were boilerplate, others were comprehensive, detailed critiques of…
In Bid to Curtail 180-day Exclusivity, FDA Alters Longstanding Practice and Newly Declares that Converted OTC Products Are Not “Listed Drugs”
…submitted is available OTC or only with a doctor’s prescription, the submission of any Paragraph IV certification entails the very risk that 180-day exclusivity is designed to compensate—namely, that it…
U.S. Cattlemen Petition USDA to Address “Made in USA” and “Product of USA” Claims
…and require that any beef product labeled as “Made in the USA,” “Product of the USA,” “USA beef,” or otherwise indicated to be U.S. beef, come from cattle that have…
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…
‘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….
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…
New REMS for Prescription Oral Sodium Phosphate Products Raises Questions on Application of REMS To Active Ingredients Available Both As Prescription and OTC
…active ingredients that are marketed, albeit at different dosages or indications, both as a prescription and OTC product. For instance, aspirin, while marketed OTC, also has professional labeling for the…
OTC Hearing Aids: “Nothing to See Here” Says GAO Report
It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress…