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 […]
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 This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information.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 […]
After more than five (5) years since the introduction of the proposed rule, FDA is issuing a final rule that adds § 50.22 Exception from informed consent requirements for minimal risk clinical investigations to the regulations. “The final rule amends FDA’s regulations to allow [Institutional Review Boards] IRBs responsible for the review, approval, and continuing […]
To all our readers – We wish you a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday, starting Friday (unless something extremely urgent occurs), and I hope that all of you will join me back in the New Year as […]
Thankfully, it looks like the FDA has been able to address its IT issues, although approvals are now appearing more than a few days after the approval letters are issued. This peek at the numbers is provided for approval information posted as of December 20th – which includes posted approvals through December 15th. As of that date, […]
The Office of Generic Drugs approved eighty-two first-time generic products in FY 2023 for fifty-two different products. For example, the OGD approved sixteen ANDAs on the same day for Lisdexamfetamine Dimesylate Capsules (the generic for Vyvanse) on August 25, 2023. Each of these is counted as a first approval because they were all approved on the same […]
Have you reviewed your audit trail lately? What is it telling you and your team? We all understand the importance of audit trails, and companies review audit trails in one way or another, but does your staff truly understand what the audit trail is stating? Processes in a GxP environment should be developed and implemented […]
Almost two and a half months after the beginning of FY 2024, the first month of FY 2024 (October 2023) statistics appeared, almost like a Christmas present! And from the looks of the numbers, there is likely some coal in some of the statistical “stockings.” Let’s start with the Original ANDA approval numbers. The OGD did pretty […]
This has been a long time coming! Ever since the first approval of isotretinoin (Accutane – by Hoffmann La Roche, Inc. on May 7, 1982), and the associated safety requirements associated with that product’s labeling, the requirements for the safe use of isotretinoin products have become stricter. This type of safety information and requirements for […]
