FDA is accepting applications from the pharmaceutical industry to pilot electronic tracking systems for prescription drugs in preparation for a Nov. 27, 2023, implementation deadline.
FDA has announced it is accepting applications from the pharmaceutical industry and its supply chain partners to participate in a supply chain security pilot program to test the use of product identifiers, barcodes and the interoperable systems used to track and trace prescription drugs through the distribution chain.
The announcement was published in the Feb. 8 Federal Register. The Drug Supply Chain Security Act, signed into law on Nov
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
