The Food, Drug, and Cosmetic Act of 1938 was precipitated by a disaster where over 100 people died, many of whom were children. In the early 1930s, a wonder drug called sulfanilamide was marketed for treatment of certain infections. The problem with the drug was that it was very bitter, and, because of this, children […]
Seemingly every day, there is news of a dietary supplement (DS) running afoul of regulations, either by containing a hidden drug ingredient or claiming the product is used in the cure, mitigation, or treatment of a disease, running afoul of the existing FDA dietary supplement regulations. Congress had the opportunity to redefine FDA oversight of […]
Analytical development and/or QC groups at early-stage pharmaceuticals and biopharmaceuticals often ask themselves about the level of level of confirmation of suitability required for their methods. Often the term ‘validation’ is used without understanding the full implications of the term. Sometimes, the terms validation, qualification and verification are used interchangeably. While ‘validation’ is well understood […]
The 2022 ISPE Pharma 4.0 and Annex 1 Conference, which just concluded in Vienna, Austria, highlighted the exploding value of digitization in pharmaceutical aseptic manufacturing and quality, and how digitization will play a key role in the attainment of sustainable and robust compliance for the new revision of EU GMP Annex 1 for manufacture of […]
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 […]
There has been turmoil in the world; everything seems to have gone crazy. It’s hard to find faith or even truth in our politicians. Laws have been broken and our democracy was almost broken. But, with the 2022 mid‑year election, we seem to have taken a step back from the precipice. In thinking about our […]
The 17th Annual FDA Inspections Summit kicked off with high energy by keynote speaker Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations Regulatory Affairs who presented on the FDA perspective on inspections. As the entire world emerges from the pandemic, it was reported that the ORA is holding “listening sessions” to see […]
Day two of the Association of Accessible Medicine (AAM) Generics and Biosimilars Conference, which took place on November 8, 2022, started with plenary session presentations from Dr. Susan Rosencrance, Acting Director, Office of Generic Drugs (OGD), Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality (OPQ), and Donald Ashley, JD, Director, Office of Compliance (OC) with the FDA. […]
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 […]
