This morning, the FDA published the OTC Monograph request Fee rates for FY 2024 in a pre-publication Federal Register notice (here); these rates cover fees for OTC monograph order requests (OMORs) for which there are Tier 1 and Tier 2 requests. The distinction for the two classifications of OMORs are a Tier 1 request (usually […]
The industry as a whole rejoiced on Friday with the publication of the new NDSRI guidance from the FDA, previously discussed here. Now that we all have had more time to carefully read and absorb the details posted by the FDA in the guidance and on the corresponding webpage, many will discover that there are […]
Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products. As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]
I remember working part-time as a pharmacist when I was at FDA and there were only a few prescription oral contraceptives that were available for dispensing at that time. If you had asked then (1984) if I thought that there would ever be an OTC version of an oral contraceptive available, I would have bet […]
The FDA has just revised its MaPP 5014.1 titled Understanding CDER’s Risk‑Based Site Selection Model. Remember, MaPP stands for Manual of Policy and Procedures, and MaPPs instruct internal FDA staff on proper procedures. The FDA publishes these MaPPs to provide greater transparency to stakeholders so they can better understand how the Agency does something or […]
Based on the longstanding knowledge that diethylene glycol (DEG) and ethylene glycol (EG) are dangerous at levels that may exceed USP‑NF limits and because of the recent misadventures and deaths resulting from these incidents, the FDA has revised a 2007 guidance to provide further recommendations regarding the identification and quantification of these contaminants in drug […]
Emergent Bio Solutions received FDA approval today to market an over the counter (OTC) 4mg nasal spray to reverse opioid overdose. What does that mean to the public and the industry? For the public, as soon as the company begins distributing the product, it means easy access to a potentially lifesaving emergency medication to treat […]
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 […]
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 […]
I usually don’t blog about Federal Register (FR) notices on collections of information as they are usually not that exciting and typically just announce the Agency’s collection of certain information as is an OMB requirement under the Paperwork Reductions Act of 1995 (as an aside, there sure does seem to be a lot of paperwork […]
