Last week, I was able to attend SBIA’s Generic Drug Forum in Bethesda, Maryland, and I’m sure that many readers of Lachman’s blog also attended virtually. The Forum offered a diverse array of presentations applicable to the generic industry at large. In this blog, I will focus on one presentation related to PLAIRs (Pre-Launch Activities […]
Although the pilot program for Parallel Scientific Advice (PSA) meetings with U.S. and the EMA for complex generics and hybrid products is relatively new, there have been only two requests for meeting participation thus far. According to the FDA, “The Parallel Scientific Advice (PSA) pilot program allows for applicants to engage in concurrent scientific conversation […]
With the first half of the month in the books and postings up through April 17, 2024, the OGD has issued thirty full-approval actions and seven tentative-approval actions. At this rate, it is possible that the OGD will hit or break sixty full-approval actions in April. This could be the first month that the OGD goes […]
What is the answer to the question? Apparently, at the FDA’s Center for Drug Evaluation and Research (CDER) Small Business Industry Assistance (SBIA) Generic Drug Forum for 2024 (held April 10-11), it was Controlled Correspondence (CC). The FDA conducted two presentations exclusively on CCs and responded with that answer on more questions than not throughout […]
At the Association of Accessible Medicines (AAM) February 2024 Annual Meeting Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director of CDER, made another interesting point in her presentation yesterday, outlining the number of national drug shortages that the FDA reported per calendar year (reproduced at the link below) and indicating that the press has reported […]
This month we will pat ourselves on the back as we captured the correct number of approval and tentative approval actions in our calculation of the unofficial numbers in our post here. We were more patient when looking at the February data from the daily approval page (which must be pieced together because it only […]
As the saying goes, March came in like a lion but went out like a lamb. The OGD issued only 48 full-approval actions and 13 tentative-approval actions for a total of 61. The beginning days of the month looked relatively strong but that kind of petered out towards the end of the month. The 48 […]
It’s not the big things that you need to worry about; it’s the little things that will kill you! And nothing is truer than that when it comes to microbial bugs that have become resistant to antibiotic therapy! The rise in “Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the […]
A review of Warning Letters issued in 2023 and 2024 (to date) by the U.S. FDA to manufacturers of drug products and cosmetics shows the presence of some findings that are seen more frequently than others. One of these is the following: “Your firm failed to test samples of each component for conformity with all […]
For the last several years, there has been a push in the industry to take a systematic approach and design quality into your systems and processes by establishing up front requirements such as QTPP for process validation and ATP for analytical methods. Such an approach provides invaluable benefits to the public whereby, the manufacturer has […]
