There has been a lot of discussion about the need to retain up to five times the amount of test and reference drug product to perform release testing as reserve samples for products used in in vivo or in vitro bioavailability (BA) or bioequivalence (BE) testing for NDA or ANDAs products. The requirements were at […]
OGD reported 69 full approval actions, which we hit on the head, (three of the full approvals were for first time generic approvals) and 13 tentative approval actions (we reported only 9, as that was all that was found on the FDA’s All Approvals site at the time) for a total of 82 approval actions […]
A Department of Justice press release (here) announced a 19 count indictment against 9 individuals “with conspiracy to commit mail and wire fraud, mail fraud, wire fraud, aggravated identity theft, conspiracy to defraud the United States, and failure to maintain adequate records.” Basically, the press release goes on to describe fraudulent activities relative to the […]
As of August 5, 2020, the FDA had posted 69 full approval actions and 9 tentative approval actions for ANDAs for July 2020. The total of 78 approval actions for the month of July fall short of the 87 Approval actions in June but appears to be consistent with the last four month’s totals. Some […]
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 […]
