14
Sep

Whoops, Lots of OTC Manufacturers Missed the Deadline – FDA Releases OTC Arrears List

The FDA published its first arrears list for failure to pay FY 2021 Over-the-Counter Monograph User Fee Act (OMUFA) facility fees.  Invoices were emailed on June 25, 2021 for fees not paid by the May 10, 2021 due date.  And, holy smokes, there are almost 500 firms on the arrears list.  Twenty‑eight are contract manufacturing organizations […]

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12
Jan
How did that happen?

So Now We Know Why the OMUFA User Fee Notice Was Withdrawn

The confusion regarding the initial publication of the OTC User Fee Act announcing the user fee structure originally published here and its subsequent withdrawal published here is (for the most part) clarified now by the January 12, 2021 FR Notice here that identifies the issue precipitating in the withdrawal. In the current FR Notice, the […]

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05
Jan
Confused businesswoman looking at camera

Whoops – Somebody Goofed!

On December 28, 2020, we published a blog post on the OMUFA fee structure for new OTC reviews and facilities (here). Today, in the prepublication of the Federal Register (FR) here, the FDA abruptly withdrew the FR Notice. Looks like someone along the way goofed as the notice bluntly indicates that “[T]he Department of Health […]

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30
Dec

Q&A Guidance on the Consumer Antiseptic Rubs Final Rule Still Places Three Ingredients in Limbo

Back on April 11, 2019, we posted on the Consumer Antiseptic Rubs Final Rule (here), which also addressed use of certain wipes.  The notice excluded 28 active ingredients from inclusion for OTC use as consumer antiseptic rubs (for example, leave on products, not to be used with water) but deferred action on three ingredients, “benzalkonium […]

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08
Dec

A Divorce of Sorts, as FDA Separates Guidance on Rx and OTC Proprietary Naming

In May of 2014, the FDA issued a draft guidance entitled Best Practices in Developing Proprietary Names for Drugs. This draft guidance contained recommendations for the selection of proprietary names for both prescription (Rx) and over-the-counter (OTC) medications.  In the 6-and-a-half-year interval that has passed since the issuance of this guidance, the FDA has initiated […]

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21
Mar

ADE Relief During Pandemic – But Only if You Need It!

The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency.  The FDA issued this Guidance directly with no public comment on March 20, 2020.  It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]

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