While most of you are aware of these facts published by FDA last week, I found this article quite interesting, and it may teach us a thing or two! And because many of our readers come from different backgrounds than us in regulatory, the FDA, or the healthcare industry, it may provide some prospective on […]
As a proud Silver Sponsor of this important conference, we’ll be looking for you at Access! 2024. This annual meeting of the Association for Accessible Medicines (AAM) is happening in Tampa, Florida at the JW Marriott from Monday, February 5th through Wednesday, February 7th, 2024. Visit with us at Booth #11. The Lachman Consultants team […]
This morning, when I read a Decision and Order issued by the United States Court of Federal Claims regarding a motion that was granted in part, denied in part, and filed on behalf of a pharmaceutical company and the FDA, the hair on the back of my neck stood on end. Now, I must state […]
Marty Shimer, Executive Director at Lachman Consultants, wrote a great post (here) about ANDA suitability petitions and the new GDUFA goal dates being assigned to them. His post gives us hope that the new system in place will provide some meaningful timelines for actions on ANDA suitability petitions used to make certain permissible changes from […]
Well, after a somewhat underwhelming start to FY 2024 (which began in October 2023), as reported here, it looks like things are picking up on the approval front for ANDAs. With approval postings through January 17th available today, the OGD has issued thirty-two full-approval actions and ten tentative-approval actions. This should bode well for a better January […]
Yesterday, the Office of Generic Drugs published the November addition to its FY 2024 Generic Drugs Program Monthly and Quarterly Activities Report (here). Officially, the OGD issued 51 final ANDA approval actions and 17 tentative-approval actions for a total of 68 approval actions. Of the 51 final approval actions, four were for first-time generics and six […]
The FDA report Advancing Health Through Innovation: New Drug Therapy Approvals 2023 (here) outlines the progress that the Agency has made on the approval of novel drugs (those “which are for therapies that have not previously been approved in the U.S.”), and provides a number of interesting statistics, so I urge you to read the […]
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 […]
