Have you ever wondered why, in many airports across different countries, there are multiple random security checks after the initial check at the entrance and before boarding the plane? Do all these intermediate checks make flying much safer? Are intermediate checks required because the initial check may not be trustworthy, or are they intended to […]
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 […]
When we reported the unofficial January approval actions in a previous blog post, there was some concern about how OGD would be reporting their approval and tentative approval actions on the daily report versus the Generic Drugs Program Monthly and Quarterly Activities Report (here). If you go back and read the January unofficial approval blog […]
The Hill report (here) that “Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) on Wednesday reintroduced legislation intended to close a loophole that drug companies can exploit to block competition, including from lower-cost generic drugs.” The bill would permit FDA to approve a drug product for a generic immediately if all other approval requirements are […]
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 […]