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 […]
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 […]
CMS realizes that some drugs approved through the FDA’s accelerated-approval process won’t prove to be safe and effective in final analysis. It wants to balance its payment for products that might not pan out in confirmatory trials by trying to make firms sprint, rather than crawl, to finalizing such studies. How? Well, we know that […]
An AAM blog posted this morning (here), titled The Quickest Route to U.S. Essential Medicines Production: Existing and Idle Production Sites, seems to think that the answer to this post’s titular question is Yes, and it at least provides another option for consideration. The AAM post cites a report (here) by Professor Anthony Sardella from […]
It’s that time of year. Taxes? Well, yes, but that’s not what I’m talking about. Instead, I’m referencing the equivalent for those of us in the pharmaceutical industry—CARES Act reporting. In the last couple of weeks, a flurry of emails arrived for many of us from the FDA, reminding us that: “Under section 510(j)(3) of the […]
As we have noted in previous posts, the OGD has two types of approval actions for the various categories of approvals and tentative approvals. What the heck does that mean? Well, let’s take an example from this month’s approval actions. On January 24, 2023, the OGD approved one fentanyl application; however, that single application had […]
“A postmarketing requirement (PMR) is a study or clinical trial that an applicant is required by statute or regulation to conduct postapproval. A postmarketing commitment (PMC) is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that is not required by statute or regulation.” In previous years, the FDA […]
The FDA exhibits a high degree of transparency in projecting its intentions and inspection plans. One has only to look at publications such as, “An update to the Resiliency Roadmap for FDA Inspections” (here) that was issued November 2021. So, one may ask, what has happened in the meantime and what is the plan for […]
