Each year about this time the FDA sponsors an Advisory Committee meeting to flush out the best guesses of experts on what would be the best composition of next season’s flu vaccines. MSN reports (here), “[T]he annual meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is crucial for drugmakers to ensure […]
There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]
A recent report in Nature Medicine (published February 17, 2025) highlights the long-term potential of Chimeric Antigen Receptor T Cell products (aka CAR-T cell therapy), showcasing an exceptional 18-year remission in a neuroblastoma patient. This milestone is particularly significant given the historical challenges that CAR-T therapy has faced in effectively treating solid tumors like neuroblastoma, even while […]
Over 30 years ago, one of my responsibilities was overseeing the company’s Reference Standard Program for marketed products. In-house standards were maintained and provided to company locations throughout the world, which also included providing enough fully characterized/qualified drug substances or impurities to the USP to be considered as a potential future USP Reference Standard lot. […]
Water is a critical component used in the manufacture of pharmaceutical products, and it must meet specific quality standards in order to demonstrate that the water intended to be used for manufacture is suitable for its intended purposes. USP <1231> on Water for Pharmaceutical Purposes provides an overview of the different water types used in manufacturing, […]
When addressing the requirements of analytical test procedures, 21 CFR 211.160 states: “Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” 21 CFR […]
Last week, my colleague and I traveled to Bangalore to attend the PDA India Chapter’s meeting on Supply Chain Resilience & Quality Management Maturity. While I was intellectually aware of the important role that India plays in the global supply chain for pharmaceuticals, during my 2½ days at this chapter meeting, I was able to […]
It’s been a pleasure to return to the PDA/FDA’s 2024 Joint Regulatory Conference. This is the first FDA co-sponsored conference that I’ve attended since my retirement from the Agency in 2023, and it has a bit of a high-school-reunion atmosphere for me. I’m grateful for the friendships with my FDA colleagues that have extended beyond […]
U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight. Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]
The WHO has a draft July 2013 guidance document titled “Deviation Handling and Quality Risk Management” that addresses the concept that not all Quality Events are equivalent and provides consideration for the classification of events. For example, an incident would be an event that does not: “…affect a product attribute, manufacturing operational parameter or the […]
