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 […]
Yesterday, the FDA published a “reminder” clarifying the status of compounded Tirzepatide now that the shortage for this GLP-1 product has been resolved. After confirming with the approved manufacturer of Tirzepatide that they now have sufficient supplies to meet current market demand, FDA is “reminding” both 503A and 503B compounders that, since the product is […]
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 […]
On September 20, 2024, we posted a blog on the changes that are being contemplated by the FDA with issuance of the final M13A guidance (here). One of the major changes delineated in this guidance was elimination of the previous requirements for fed bioequivalence studies in over 850 different Product Specific Guidances (PSGs) for solid oral […]
Last week, my colleague and I traveled to Bangalore to attend the PDA India Chapter’s meeting on Supply Chain Resilience & Quality Management Maturity. While I was intellectually aware of the important role that India plays in the global supply chain for pharmaceuticals, during my 2½ days at this chapter meeting, I was able to […]
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, […]
From September 18 to 20, 2024, I was pleased to attend the PDA India Chapter conference on Quality Management Maturity and Supply Chain Resiliency, and I was impressed with the number of people who took three days out of (what must be) busy schedules and demanding jobs in the Indian pharmaceutical industry to attend. […]
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 […]
