Just a brief follow-up on our post of October 3rd (here) regarding the FDA’s determination that the drug shortage for Tirzepatide is over and the Agency’s “reminder” that, because the shortage has been resolved, 503B compounders should no longer be making the product. Well, a story by Brendan Pierson published by Reuters today (here), titled […]
Well, there is bad, then there is worse! In this case, the FDA warns us about a product that is being marketed as all natural and promoted as a dietary supplement for joint and muscle pain. The product, called Trinity Gold, actually contains three undeclared drug ingredients, acetaminophen, diclofenac, and phenylbutazone (which was removed from […]
The following chart represents the planned activities of the FDA to address certain OTC monographs over the next three years. The agency notes that while this list is aspirational, the list is not binding (what is with the FDA?). For those of you familiar with the old OTC monograph process, three years does not seem […]
Well, here we are at the end of Fiscal Year (FY) 2024 and, because we likely will not see official approval action totals for the last two months of the FY until sometime in November, we will take a stab at giving you the best estimate we can. For September, the unofficial approval actions look […]
According to a post yesterday (here), the Association for Accessible Medicines (AAM) Board of Directors has announced the appointment of John A. Murphy, III as the association’s President and Chief Executive Officer. Mr. Murphy will join AAM in October from the Biotechnology Innovation Organization (BIO) where he served as Chief Policy Officer. Mr. Murphy is a lawyer and, […]
It was on September 24, 1984 that Congress gave birth to the Drug Price Competition and Patent Term Restoration Act, also known today as Hatch-Waxman (at the time of the Act’s passage, it was called Waxman-Hatch because the Democrats were in power). For those of you who don’t remember or weren’t even born when Hatch-Waxman […]
Historically, and in most cases, industry knows that it will certainly be required to perform both fasting and fed bioequivalence studies on solid oral immediate-release products or it may have an option to seek a waiver of in-vivo bioequivalence requirements for BCS Class 1 drugs. However, a few days ago, the FDA published a listing of […]
Some of you have asked why we keep such a close eye on ANDA approval actions. It is a valid question. Knowing the importance of moving freight through the OGD comes from a combined 40+ years of experience, both in the OGD and in industry, and it is clear to me that this is the […]
Reviewed “under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device,” the Agency has approved an OTC software solution that is compatible with certain Apple AirPods Pro headphones and provides, according to the FDA release […]
With savings continuing to rise, are we at the apex of the climb or should we be worried? Generic drugs continue to struggle with uptake and placement on formularies, even Medicare Part B, which is where one would assume uptake would be the highest. PBMs place generics on higher tiers in favor of brand-name rebates because […]
