28
Nov

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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15
Nov

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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01
Nov

OTC Monograph User Fee (OMUFA) Draft Guidance Published Today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you in the OTC monograph world (not OTC products that require an approved NDA or ANDA application for marketing), this draft guidance document, titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (here), will provide you with the how, what, and when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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08
Sep

 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The FDA released a draft guidance titled Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products: Guidance for Industry (here) which, not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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17
Aug

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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21
Apr

The Hammer Comes Down on Hydroquinone Cream

Used for years as an “unapproved” drug for lightening of skin color, the FDA issued warning letters to twelve firms selling the drug, telling them that hydroquinone is not generally recognized as safe and effective. On August 29, 2006, the FDA issued a Notice of Proposed Rulemaking that would establish that over-the-counter (OTC) skin-bleaching drug […]

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25
Mar

March 31 End Date for Alcohol Hand Sanitizer Distribution Under Temporary Policy

In an announcement today, the FDA reminded manufacturers of alcohol-based hand sanitizers that they can no longer distribute products made under the temporary policy, which was withdrawn on December 31, 2021 and gave manufacturers until March 31, 2022 to comply (see the announcement here). The Agency notes that distribution from manufacturers to all outlets, which […]

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14
Mar

OTC User Fee Rates Published Today

The FDA published the OTC User Fee rates for FY 2022 today  These rates were announced this morning in a Federal Register notice (here) and cover fees for OTC manufacturing facilities, contract manufacturing organizations (CMO), and OTC monograph order requests (OMOR) for which there are tier 1 and tier 2 requests.  A comparison of the FY […]

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01
Feb

CARES Act Manufacturing Quantities Reporting Requirement – Better Sharpen Your Pencils!

Back in November 2021, the Lachman blog brought your attention to the changes coming with the new FDA reporting requirements that were instituted under the March 2020 CARES Act (section 3112(e)) when it was reported at the AAM GRx-Biosims conference.  This new law, enacted for COVID‑19 response and relief, includes “enhanced” abilities for the FDA […]

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