On October 1, 2021, the FDA published the first list of monograph activities that will be prioritized to address areas of concern and the GRAS status of certain products under the new monograph system. The plan is currently to address these issues over the next few years; however, the Agency does not commit to assessing […]
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 […]
The FDA will publish a notice in the Federal Register tomorrow (May 13, 2021) that announces a notice of intent to scope out the need to issue an environmental impact statement relative to certain sunscreen active ingredients (namely oxybenzone and octinoxate) and their potential impact on the health of the coral reefs. This notice of […]
In a podcast, FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm (here). The warning first came from FDA on March 25, 2021 in the form of a drug safety communication (here). The product marketed as Benzedrex is safe and effective when used in accordance with its […]
A Federal Register notice published on March 26, 2021 announced the Over-the-Counter (OTC) Monograph User Fee rates for the Agency’s newest UFA, OMUFA, 2021. There are two types of user fees; one is for facilities of firms that manufacture and distribute OTC products (monograph drug facilities (MDFs)) and the other is for a subset of […]
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 […]
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 […]
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 […]
Another UFA – sounds like the noise an animal cartoon character might make. It is, however, no laughing matter. “On March 27, 2020, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Coronavirus Aid, Relief, and Economic Security Act, which authorizes FDA to assess and collect user […]
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 […]