In recent years, there have been endless FDA actions on adulterated and/or misbranded dietary supplements. In addition, almost every week, there are warning letters or FDA public health announcements regarding dietary supplements released by the Agency. The FDA does not approve dietary supplements, but they do regulate them. This is a confusing area for the […]
CDER has issued the final guidance, ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products, which provides for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM), applying to both drug substances and drug products for chemical entities, therapeutic proteins for new products, and conversion of existing products. A copy of the guidance […]
The Office of Generic Drugs has published its 2022 Annual Report (here), outlining its accomplishments over the year. As a reminder, this report has multiple sections and you can click on each section to see its contents once you are in the report; simply continue to scroll down until your fingers are tired. It’s important […]
Most companies will recognize and state that their most important assets are the people who work for them, which is naturally also the case for the pharmaceutical industry. It goes without saying that the number of staff and their competency can have a consequential impact on product quality/patient safety, and this is recognized by health […]
With the prevalence of COVID-19 still relatively high, with flu season upon us, and with symptoms of both infectious diseases being pretty much the same, how many of you have wondered when sick, Do I have COVID or the flu? You could always test for COVID but never had the option to home test for […]
When a reference listed drug (RLD) product is discontinued from marketing, or if the RLD’s NDA application is officially withdrawn, we all know that the FDA must make a determination that the specific RLD was not discontinued from marketing or withdrawn for safety or efficacy reasons before it can approve an ANDA based on the […]
February is a short month in workdays and it may be the same for approvals. Through February 17th, the OGD has issued twenty‑five full‑approval actions and fourteen tentative‑approval actions. With only six reporting days left this month, unless there’s a big surge in the next few days, we may be looking at the fewest approval […]
We have seen several changes from FDA with the roll-out of GDUFA III. Some have been a little frustrating (Controlled Correspondence blog coming soon!), but some have been pretty great! On February 17, 2023 FDA issued a new GFI, “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA” (here). This GFI seems to point […]
The release of CDER’s OPQ 2022 Annual Report is a grand opportunity for an “Agency and industry” calibration to ensure alignment of performance and strategy. In any journey, it is prudent to check your compass, map, and progress to date to ensure your trip stays on course. The report efficiently states the strategic priorities, performance […]
Hello from sunny Orlando and the AAM annual meeting! The FDA’s Jacqueline Corrigan-Curay, Principal Deputy Director, CDER, FDA, had the honor of providing the FDA’s keynote address. She started her talk by highlighting some of the accomplishments of GDUFA II, such as calling out the 490 first-generic approvals and 553 complex-generic approvals out of a total […]
