According to the unofficial August numbers derived from the FDA’s All Approvals list (here), the Office of Generic Drugs issued 58 full approval (AP) actions and 10 tentative approval (TA) actions during the month of August 2020. The number of APs and TAs are both the lowest number of approval actions in the past 7 […]
The Drug Price Competition and Patent Term Restoration Act of 1984 (better know as Hatch-Waxman) provided a balance between innovation and competition by permitting generic drugs to rely on the safety and efficacy of a previously approved reference listed drug (RLD) rather than unnecessarily repeating duplicative clinical testing to prove what was already known about […]
The FDA has backed away and revoked a number of Emergency Use Authorizations (EUAs) that it had issued in the past, including those for hydroxychloroquine and a multitude of less-than-accurate COVID‑19 tests. By all accounts, there is a degree of trepidation in the scientific community that many of the Agency’s decisions regarding EUAs are being […]
The Office of Generic Drugs released nineteen new and ten revised bioequivalence recommendations today. The Federal Register Notice (here) lists two tables with the new and revised recommendations as presented below: There are always concerns, when an existing guidance is revised, as to how it might impact […]
With six (6) reporting days left in the month, the FDA’s All Approvals List (here) has identified 43 full ANDA approval actions and 10 tentative approval actions. While this represents a bit slower pace for approval actions, there is still time to meet FY 2020 monthly averages by the end of the month. We want […]
Clearly, the FDA has acted too early on Emergency Use Authorizations (EUAs) for a few COVID-19 tests and products. The flurry of revocations of EUAs for tests that were deemed not reliable have cause a sputter in the onset of testing ramp up. Another specific example was the FDA’s EUA for hydroxychloroquine, which left many […]
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 […]
In any analytical laboratory that performs cGMP testing, data review is required. However, to an analytical chemist that prefers benchwork, reviewing the data of a fellow analyst is often deemed an undesirable chore. The data reviewer rarely gets a “Thank you” for pointing out irregularities in documentation. The role of the data reviewer is to […]
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 […]
