In a prepublication Federal Register notice here, the FDA announced its FY 2026 OTC monograph order requests (OMOR). The Agency has indicated that it will publish the FY 2026 OMUFA facility fee rates (i.e., monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates) in a subsequent Federal Register notice. There are two tiers of […]
New MaPP 5200.11 (here) provides an outline of internal FDA policy applied when an NDA product makes a full OTC switch. A partial OTC switch means there is a “leave behind” indication in the NDA product that still requires a prescription. This can be a use, a dose, or a related disease state. This MaPP […]
The FDA has made clear that it is interested in hearing your thoughts on the OTC drugs approved through the NDA process and wants your feedback on a number of topics. In a pre-publication notice in the Federal Register yesterday (here), the FDA noted that it would like interested parties to “share their perspectives with […]
As we near the end of October 2025, the first month of new FY 2026, and as FDA appropriations languish in our dysfunctional Congress, the number of fee-paying submissions submitted to FDA so far in the new Fiscal Year 2026 = 0. That’s right nada, nil, zero, zilch, none. You can count the number on […]
Almost everywhere you go, whether at a gas station, health store, supermarket, or on the internet, there are advertisements and/or an opportunity to purchase CBD (cannabidiol), a byproduct of hemp that is a non-psychoactive cannabinoid. According to the FDA, cannabidiol occurs in relatively high levels in hemp. Ever since the passage of the Agricultural Improvement […]
On July 21, 2025, the FDA published its updated Over-The-Counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists. The updated versions can be found here for the facility arrears list and here for a download of the paid list. If your facility is still engaged in the manufacture of OTC products and […]
For those of you who are required to pay the OMUFA manufacturer’s fees that were due on June 2, 2025 but failed to do so, your name may appear on the OMUFA Facility Arrears List (here). Remember, failure to pay the required fees will result in the FDA finding all of your OTC products misbranded. To […]
Today, the FDA published a draft guidance titled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (here). This document discusses the conditions under which minor changes in dosage form (i.e., tablet or capsule to chewable tablets, orally disintegrating tablets (ODT), […]
Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.” What a dandy, […]
The FDA warns about the potential for rare but severe itching after discontinuation of cetirizine or levocetirizine for both over-the-counter (OTC) and prescription drug products (here). The FDA says, ”[t]he itching, also called pruritus, has been reported in patients who used these medicines daily, typically for at least a few months and often for years. […]
