On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”. This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency. As is no surprise, FDA clearly […]
We were close on our unofficial approval numbers for December reported here for approval actions and tentative approval actions (63 and 20 respectively) as the official numbers reported today by OGD are 63 and 22, respectively. Looks like 2 TAs snuck onto the approvals listing late in the game. Of the 63 approval actions in […]
While reading a blog post by Michael Mezher of RAPS this morning, entitled HHS Pushes Through Last-Minute Policies Impacting FDA (here), it struck me that my own age old question is almost (and I stress almost) being addressed. The question is, when a regulation or statute directs the FDA to meet certain review timeline requirements, […]
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 […]
In a continuing effort to deal with the number of ANDAs, supplements, and bioequivalence work and maintain a consistent and uniform quality of its reviews, the Office of Generic Drugs will be moving forward with a reorganization plan that will likely be effective sometime later in 2021. In the announcement received via email this morning, […]
As we hoped in our post here, the unofficial approval numbers for December were pretty good. As of postings on the FDA’s All Approvals list as of January 7, 2021 (here), OGD posted 63 full approval actions and 20 tentative approval actions for a total of 83, up from the November 76 total approval actions. […]
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 […]
Ever since November 24, 1984, the effective date of the Drug Price Competition and Patent Term Restoration Act (aka Hatch-Waxman) which created the unique and delicate balance between innovation and safe and effective high quality generic copies of brand name products, the use of the “skinny label” has been a touchstone of that balance. Rather […]
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 […]
