“Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy designation under section 506H of the FD&C Act.” These […]
The OGD unofficially issued 53 full approval actions and 16 tentative approval actions for a total of 69 approval actions. For a month with only twenty-eight days and one federal holiday, the OGD’s approval-action total is not too bad. Coupled with the great uncertainty regarding terminations and reduction in force of CDER employees, I think […]
Almost two months to the day, the OGD published its final December statistical report along with the Quarterly Report on approval times for the first three months of FY 2025. It appears that the OGD did better in ANDA approval and tentative approval (TA) actions than we had reported back on January 6, 2025 in […]
Each year about this time the FDA sponsors an Advisory Committee meeting to flush out the best guesses of experts on what would be the best composition of next season’s flu vaccines. MSN reports (here), “[T]he annual meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is crucial for drugmakers to ensure […]
As consultants we have the privilege of assisting many clients with FDA communications on a variety of topics and working with them to support many different types of drug product applications. Through our work we often identify common themes or issues that our clients are facing and one of the biggest headaches for our ANDA […]
As many in industry are already aware, suitability petitions began to be subject to review metrics at the beginning of Fiscal Year 2024, which started on October 1, 2023. As a reminder, the GDUFA III Commitment Letter (GIII CL) requires the FDA to review and respond to suitability petitions that have been assigned a goal date within six […]
There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]
Not too long after Patrizia Cavazzoni, M.D. left the FDA as Director of the Center for Drug Evaluation and Research (CDER), according to Drew Armstrong’s article in Endpoints News (here, subscription required), she landed at Pfizer where she was hired as Chief Medical Officer. She had worked at Pfizer previously and left the Agency shortly […]
According to one of the few Federal Register (FR) notices we have seen relating to FDA activities, today’s pre-publication page of the FR notes that “[i]n accordance with the memorandum of January 20, 2025, from the President, entitled ‘Regulatory Freeze Pending Review,’ the effective date of the final rule entitled ‘Food Labeling: Nutrient Content Claims; Definition […]
In the Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy) issued by the FDA on February 21, 2025 (here ), the Agency indicates that the supply of the innovator products either meet or exceed demand for Semaglutide Injection products. While the FDA acknowledges that there may be some patients that continue […]
