Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products. As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]
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 […]
“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 […]
Whether it be the supply chain, compliance issues, manufacturing issues, issues with packaging components, or just plain bad luck, the number of drug shortages continues to plague the pharmaceutical industry both domestically and overseas. The FDA current shortage list (here) contains 191 entries and, of that number, only 66 have been resolved, leaving 125 drug […]
Today’s pre-publication of the Federal Register contains a proposed rule (here) that will require the expansion of the current IND annual report. “Current § 312.33 requires sponsors that have an IND in effect to submit an annual report that must contain individual study information, which generally includes brief summaries of the status of each ongoing […]
Two years after the FDA guidance on Control of Nitrosamines Impurities in Human Drugs and nearly a year after the publication of USP’s General Chapter <1469> Nitrosamine Impurities, where are we now and what have we learned? That was a question posed recently at the Association of Accessible Medicine’s GRx+Biosims 2022 conference. The session devoted […]
Is a mature pharmaceutical quality system really a competitive advantage? The industry held this as a belief, but progress in a tangible program was always elusive. On November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature […]
So, you have just been granted a face-to-face (FTF) meeting with the FDA. Woohoo! You’re going to Bethesda! Don’t be too quick to make those plane and hotel reservations. This morning, the FDA published a clarification from the FDA, CDER, Small Business and Industry Assistance (SBIA) program in its INDUSTRY NEWS section titled FDA Describes […]
Today the FDA issued a guidance entitled Cross Labeling Oncology Drugs in Combination Regimens (https://www.fda.gov/media/162806/download) that describes the Agency thinking on cross labeling of oncology drugs for which there is a proven benefit from their combined use. As I read the guidance a few things popped into my mind. How can one firm who owns […]
Anyone who has been involved in basic science knows that the ultimate goal is publication of your research in a peer reviewed journal. If you work in discovery in a firm, the goal is the same, and the company looks to commercialize promising leads as potential therapeutics. We are happy to announce that one of […]
