Today, the OGD published a list of 29 new Product-Specific Guidances (PSGs) and 33 revisions to existing PSGs, all of which have been added since February 15, 2024. The listing can be found here. This publication is different than the one we wrote about in another blog today regarding the FDA’s plans for issuance of new […]
Well, the first full quarter of FY 2024 results are in (here) and, while hardly astonishing by current standards, there was some good news revealed regarding new ANDA submissions. Also, in a later post, we will provide our first full fiscal year estimates of ANDAs approved and received. The OGD officially issued 53 approval actions in […]
At the recent AAM meeting, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, CDER, provided an overview of the current state of activities at the Agency regarding biosimilar development and approvals. The FDA has been quite successful in implementing its biosimilar program and has moved the needle on approvals. Here are some of the points […]
Doug Long has become a fixture at AAM meetings, providing invaluable data on the drug industry on behalf of his employer, IQVIA. This presentation is always the highlight of AAM annual meetings. All attendees at this meeting make sure to have their seats nice and early to hear his state of the generic and biosimilars […]
At yesterday’s AAM annual meeting, David Gaugh, AAM’s interim President and CEO, discussed the unprecedented events that threaten the sustainability of today’s generic drug and biosimilar industry. In his keynote address, he addressed how the generic drug and biosimilar industry is being stressed by economic issues, PBMs, government programs, and other events out of its […]
January 2024 approval actions show that the FDA is moving in the right direction. The OGD unofficially issued 55 full-approval actions as well as 19 tentative approval actions for a total of 74 approval actions, a significant jump from December’s unofficial total of 59 total approval actions (52 full and 7 tentative). We are waiting […]
During her session yesterday at the AAM Annual Meeting, Iilun Murphy, M.D. provided additional details on the 2023 OGD metrics, indicating that there were 950 ANDAs approved and tentatively approved (782 and 172 approvals, respectively). Of the approvals, there were 90 first generics, along with 83 generics with Competitive Generic Therapy Designation, and 111 complex […]
Since the implementation of the CARES Act reporting requirement, the question continues to be asked: Is it really a requirement? The answer is yes, and now it is no longer recommended, but is stated as “should” in the newly published Final version of the Guidance for Industry (GFI) “Reporting Amount of Listed Drugs and Biological […]
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. […]
