I last wrote about the topic of ANDA Suitability Petitions (SPs) in August 2023. At the conclusion of that blog post, I referenced an SP response that had been issued in April 2000 for a SP that was submitted in November 1999, which amounted to completed review and response by the FDA in less than […]
The Office of Generic Drugs unofficially issued 52 full approval actions and 11 tentative approval actions in December 2023. Not bad considering it was the holiday season and (in fact) a tad better than the most recent holiday season of December 2022 when OGD also issued 52 full approval actions and just 7 tentative approval […]
The FDA published the Generic Drugs Program 2023 Fiscal Year Web Posting (here) on December 28, 2023. This document reflects the FDA’s performance for meeting GDUFA goal dates for FY 2023 submissions. The document meets the required reporting of certain performance metrics as outlined in the GDUFA III commitment letter. Bravo to the OGD for getting the report […]
In 2011, the FDA published the draft “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency” (here) that established the way that the FDA would prioritize, develop, and release guidances in draft or final, and identified two levels of guidances, a so-called Level 1 and Level 2. A Level 1 guidance document is one […]
With 2024 coming up fast, we thought it would be good to look back at some of the more impactful changes to the quality landscape that came about this past year. Here are just some of the stories from the Lachman blog that exemplify a productive year 2023 for our industry. Get Ready for […]
The FDA’s action is being taken to address a safety issue associated with the need to reformulate drug products that contain carbomers manufactured with benzene. The goal is to expedite and provide a clear and less burdensome path than might otherwise be required under the applicable Scale Up and Post Approval Changes (SUPAC) guidances for […]
On December 27, 2023, the FDA released a revised draft version of its October 2023 guidance titled Quality Considerations for Topical Ophthalmic Drug Products: Guidance for Industry. This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information. The […]
The title of this article is unfortunate, but all too true! We have blogged about dietary supplements with undeclared drug ingredients, dangerous products like Kratom with its inherent safety issues, and a host of other unapproved prescription or OTC drug products that continue to appear in the marketplace. But this one takes the cake! The […]
Join Lachman Consultants at the Fierce Pharma “Fierce JPM Week” in San Francisco, Jan 9 – 10 for two days of insights and engaging discussions exploring the latest in innovation, artificial intelligence, and what is on the mind of some of the top executives in the industry. Lachman will be represented on-site by members of […]
Protecting us from our own technology has never been easy. On December 8, 2023, the EU reached a milestone to help us do just that, by reaching a provisional agreement on the first dedicated law on the use of artificial intelligence (AI). This breakthrough legislation is one of the first comprehensive attempts globally to regulate […]
