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 […]
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 […]
This has been a long time coming and perhaps the impetus was Florida’s suit against the FDA for taking so long to authorize the program, but now the fun begins. The letter to the Secretary of the Florida Agency for Health Care Administration authorizing the Canadian drug import program (here) provides a laundry list of […]
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 […]
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 […]
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 […]
