When you can’t wait for answers to your GMP questions, it’s time for Lachman OnCall™. Our Subject Matter Experts (SMEs) understand you need advice right away. Lachman’s SMEs have the knowledge, experience, and skills to address your most urgent scientific, technology, and compliance-related questions, such as: “We had to shut down our sterile manufacturing plant […]
In an opinion piece in USA Today (here), eight career executives at the FDA, Patrizia Cavazzoni, Acting Director of the Center for Drug Evaluation and Research, Peter Marks, Director of the Center for Biologics Evaluation and Research, Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, Judy McMeekin, Associate Commissioner for Regulatory […]
Although we were caught off guard by a slightly early update to the July metrics which preceded Official August approval and receipt numbers, we are happy to present them to you at this time. OGD issued 4 refuse-to-receive (RTR) actions and all four were for standard ANDAs. The Agency acknowledged (filed or received, whatever you […]
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 […]
