FDA Commissioner Stephen M. Hann’s piece on the FDA website (here) provided, I believe, a very realistic view of what one might call a runaway CBD industry (if you read between the lines). “The Agriculture Improvement Act of 2018 – which, among other things, changed federal law so that cannabis and cannabis derivatives with very […]
Because we know that information regarding approval actions of original ANDAs is critical to the industry, we track them as closely as we possibly can in order to give the readers the latest information. The full approval and tentative approval actions are the lifeblood of the industry. February 2020 continues on the lower end, and […]
For those of us in regulated industry, we all treat guidance from FDA with as much reverence as the tablets that Moses carried down from Mt Sinai. However, for those of us who are not employed by FDA, the processes underlying the issuance of these guidances is very opaque and mysterious, and, for those involved […]
While it is no surprise, the prepublication notice in the Federal Register today (here) announces the withdrawal of the FDA guidance Exocrine Pancreatic Insufficiency Drug Products–Submitting New Drug Applications. The announcement comes just 19 days prior to the date when these products can no longer be submitted as an NDA. Remember, FDA had noted in […]
Well, here we are in 2020, almost halfway through GDUFA II, and what do we know? We know that the OGD expects approvals to slow down, but original ANDAs to begin to fill up the system again. We have already seen the slowdown in approvals and, according to the OGD, this is likely to continue […]
Daraprim (pyrimethamine) Tablets 25 mg first made news in 2015 when Martin Shkreli (also known as “the most hated man in America” and “Pharma Bro”) was the head of Turing Pharmaceuticals and raised the price of this NDA drug product some 5,000%, from $13.50 a tablet to $750 a tablet. (Shkreli was charged in federal […]
Reports of Secretary Azar’s comments regarding not being able to assure affordability of vaccination for all is a sign of the times we live in now. Now, I agree that a pharmaceutical company that can develop a vaccine to this deadly virus should be compensated fairly, but, if the United States fails to assure the […]
Well, I am back from three weeks of traipsing around South America and ready to hit the blogging trail again. Thanks to all my Lachman colleagues who took up the charge and did a great job in my absence. However, while away, I tried to keep up by reading the trade press when I had […]
The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here). A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]
Today, the FDA published in a final rule (here) a significant revision to the regulatory definition of biological product that will have a major impact on what product will be regulated under the Public Health Service Act (PHSA), and which will be regulated solely under the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, the […]
