Now that Dr. Marty Makary, MD, MPH, has been confirmed and appointed as FDA Commissioner, much of the Agency does not look the same. The morale at the FDA, from what I hear, is at an all-time low. And now, with reports of the reduction in workers’ safeguards along with actions as to what appears […]
As we approach the last week in March, we now have one-third of FY 2025 behind us. January’s ANDA approval numbers continue to look good, as we discussed in our February 6, 2025 post on the unofficial January approval actions (here). Another month with 90 total approval actions is good news for industry. The monthly total is […]
The old saying “March comes in like a lion and goes out like a lamb” might apply to March 2025 as the OGD has issued 34 full-approval actions and 17 tentative-approval actions through March 17th. The biggest day was the first business day of March when the OGD pushed out eleven full- and four tentative-approval […]
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 […]
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 […]
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 […]
Even though it is February 21, 2025, we are only reporting ANDA approval actions posted through February 14, 2025, because approval actions have been slow to post on the daily approvals listing on the FDA web site, possibly impacted by the pause in the FDA communications imposed by the new administration. Thus far, through February […]
At the Association for Accessible Medicines (AAM) Annual Meeting (aka Access! 2025), the Science and Regulatory Affairs Working Group met on February 3, 2025. This session is always a highlight, and one of my favorite sessions, offering insight into key regulatory and scientific issues that the AAM is currently tackling as well as those that it […]
“Disruption” was the common theme expressed by many panel members at this year’s Access 2025 meeting of the Association for Accessible Medicines in Amelia Island, Florida. In speaking to attendees, “I just don’t know what to expect” seemed to be the mantra of the day. The absence of FDA attendees also seemed to shake the […]
