FY 2023 OTC User Fees Announced

This morning, the FDA published the OTC User Fee rates for FY 2023 in a Federal Register notice (here); these rates cover fees for OTC manufacturing facilities (MFD), contract manufacturing organizations (CMO), and OTC monograph order requests (OMORs) for which there are tier 1 and tier 2 requests.  A comparison of the first three fiscal years is presented […]

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FTC Issues Newly Revised Health Product Compliance Guidance – How About That!

Just one day after expressing my opinion that more needs to be done to enhance dietary supplement regulations and requirements, I found that the FTC recently revised an older guidance (from 1998) entitled Dietary Supplements: An Advertising Guide for Industry. The new guidance entitled Health Product Compliance Guidance (here), was issued on December 20, 2022 […]

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Holidays Got You Sufferin’ – Need Some Bufferin – Not to Worry!

The November 23, 2022 issue of the Federal Register (here) contained a Proposal To Withdraw Approval of a New Drug Application for Bufferin (Aspirin) Tablets (NDA 006499) originally approved June 30, 1948 thought to still be held by Bristol Myers.  The Agency proposed to withdrawal this NDA for failure to submit required annual reports.  It […]

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OTC Naloxone Coming Down the Road?  FDA Would Like to Think So!

The opioid/fentanyl crisis, along with the abuse of other opioid‑based products, has put the prospect of an over‑the‑counter (OTC) version of naloxone high on the FDA’s priority list.  Making the product available in a ready and easy‑to‑use format (for instance, a nasal spray or autoinjector) would increase the availability of this potentially life‑saving drug.  Now, […]

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OTC Monograph User Fee (OMUFA) Draft Guidance Published Today

For those of you in the OTC monograph world (not OTC products that require an approved NDA or ANDA application for marketing), this draft guidance document, titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (here), will provide you with the how, what, and when information about facility fees for dosage-form manufacturers […]

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 OTC Statement of Identity Advice Given in FDA Guidance

The FDA released a draft guidance titled Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products: Guidance for Industry (here) which, not surprisingly, addresses the requirements for statements of identity and strength designations on the principal display panels (PDPs) of OTC drug products.  The guidance notes that “[T]he […]

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Now Hear This!

With the long-awaited FDA final rule on OTC hearing aids entitled Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids is now on the books, the Agency has issued a final guidance (here) on these products which explains the differences between, and the new regulatory framework for both hearing aids and personal sound […]

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