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...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
