The Inactive Ingredient Database (IID) has been around for a long time, but it was not very user friendly, was not updated frequently, and failed to provide something we call the maximum daily exposure (MDE) for each inactive ingredient in each route of administration. Well, FDA has been working on the list of inactive ingredients […]
The GDUFA fees for FY 2021 we announced today on the Federal Register pre-publication page (here). The new fees will be applicable for all submissions submitted on or after October 1, 2020. The FY 2021 fees with a comparison to the FY 2020 fees appear in the table below. GDUFA FY 2021 Fee Schedule Fee […]
In the Generic Drug User Fee Amendments Reauthorization Act (GDUFA II), OGD committed to provide a quarterly report with certain metrics regarding their workload and mean and median approval times for full approval actions and tentative approval actions. As you can see from the numbers below, the number of ANDAs awaiting action at OGD is […]
With five reporting days left in the month, the OGD reporting approval actions captured in the Daily Approvals list (here) and the All Approvals list (here) totaled fifty-eight full-approval actions and only four tentative-approval actions. This gives the OGD a chance to break the total approvals total for any month in FY 2020 if it […]
Proposed Law Would Provide Pathway for Generic Drugs Labeling Changes with a Reasoned Approach Proposed H.R. 5668 (here) titled, Making Objective Drug Evidence Revisions for New Labeling Act of 2020, outlines a path forward for making generic drug labeling changes when the reference listed drug is no longer marketed. We all understand the history of […]
Two prepublication Federal Register (FR) notices provide the backdrop for the historical demise of several products, and, with the final decision being affirmed that the products lack substantial evidence of effectiveness, they may no longer be marketed unless a New Drug Application with clinical data supporting the indications is submitted and approved. Vasodilan injection and […]
Well, there were some hidden tentative approval actions that must have been posted fairly late after June was over as the OGD official numbers released for June show OGD had 14 Tentative Approval (TA) actions (we reported just 5 in our post on July 6 [here]). (However, when looking at the FDA all approvals list […]
Well, June was apparently another good month for the OGD FDA work-from-home teams as the unofficial counts of the numbers show they managed 74 full approval actions and 5 tentative approval actions. The 74 full approval actions represented the highest total in a single month thus far in FY 2020, beating the next highest of […]
This morning I read Joe Graeden’s (The People’s Pharmacy) article titled “Can You Trust Generic Drug Quality” (here) and, as a former longtime senior official at the FDA who worked in the Office of Generic Drugs and have consulted for the industry for over twenty-five years, I had a kind of knee-jerk reaction and wanted […]
The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2. Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]
