So, after Monday’s blog post, All’s Quiet On the Eastern Front (here), I woke up this morning to the first signs of at least some normality at the OGD. First, ANDA approval numbers began appearing on the Daily Approvals page and the Small Business and Industry Assistance webpage. On top of that, the first day […]
Given all that’s happened with the federal government this past week, it’s no wonder that we’re not hearing much from the OGD. Communications appear to be quite slow to appear. Even the Federal Register prepublication page has few FDA postings over the last three weeks. Another instance of communication lapse: since March 7, 2025, only safety […]
If you received one or more reminder emails in November 2024 asking your firm to submit 2023 CARES Act reports, you are not alone. In 2024, the FDA emphasized the importance of CARES Act reporting and the Agency’s need for the data contained in those reports at several conferences, but there have continued to be […]
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 […]
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 […]
The FDA has updated the original nitrosamine impurity guidance after publication last year of Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (here), also known as the RAIL guidance, caused a few disconnects between the two guidances. Now that we’ve all had more time to carefully read and absorb the updates in the […]
It’s been a pleasure to return to the PDA/FDA’s 2024 Joint Regulatory Conference. This is the first FDA co-sponsored conference that I’ve attended since my retirement from the Agency in 2023, and it has a bit of a high-school-reunion atmosphere for me. I’m grateful for the friendships with my FDA colleagues that have extended beyond […]
A couple of months ago, when we returned from Barcelona to San Francisco, it was impossible to check in online for some reason. Then the news broke about flight disruptions due to the CrowdStrike software update! Some flights, including ours, were only a couple of hours delayed. However, many more passengers were affected even further […]
The FDA’s long-awaited QMSR will be released in February 2026. The amended 21 CFR 820 will incorporate by reference the Quality Management System (QMS) requirements of the 2016 edition of ISO 13485. We will explore the key differences between an FDA inspection and a notified body audit as well as the distinctions between ISO 13485 and the QMSR. […]
Yesterday, the FDA announced the issuance of 14 new product-specific guidances (PSGs) and 54 revised guidances that provide the FDA’s current thinking on the requirements for bioequivalence testing for generic drugs (here). In addition, the FDA updated its list of planned PSG issuances (73 new PSGs) as well as the list of PSGs that it […]
