A presentation delivered by Office of Generic Drugs Director, Iilun Murphy, M.D. during the members-only Regulatory and Policy meeting at the start of AAM’s annual meeting provided seven tips for ANDA sponsors with regard to their ANDA submissions: Submit a clear cover letter. Describe what is being submitted. State whether the submission includes a labeling […]
The 101-page Federal Register (FR) document published on the prepublication page of the FR today (here) describes the rule in detail and provides responses to comments received by stakeholders on the proposed final rule. The FDA states: “We are amending part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes. […]
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 […]
Some of the big-ticket items mentioned in the FY 2023 report are Office of Compliance (OC) actions taken regarding the “contamination from diethylene glycol and ethylene glycol (DEG/EG), potentially harmful eye products, and mitigating risks from drug shortages while ensuring the safety our drug supply.” These issues caused the OC to “pivot” from its business as […]
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 […]
