First, please be aware that many of the numbers you may have seen reported in our blog posts for various OGD actions were reported for Fiscal Year 2023, which ran from October 1, 2022 through September 30, 2023. The Office of Generic Drugs 2023 Annual Report (here) is a bit different as it reports OGD actions from […]
Based on approvals posted through February 16, 2024, the OGD has issued 28 full-approval actions and 5 tentative-approval actions so far in the month of February. Given that February is a short month to start with and has one federal holiday, we may get additional help as it’s a leap year and the additional day may […]
ICH Q7 refers to the need to establish the impurity profile for an Active Pharmaceutical Ingredient (API): “An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process should normally be established for each API. The impurity profile should include the identity or some qualitative […]
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 […]
Today, the FDA published a list titled Upcoming Product-Specific Guidances for Generic Drug Product Development, which can be found here and has two sections: Planned New PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024) Planned Revised PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024) Section 1 contains a list […]
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 […]
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 […]
