The change would let FDA forcibly pull prescription and over-the-counter drugs off the market just like vaccines, medical devices and other products.
The US Food and Drug Administration would receive long sought-after authority to issue mandatory recalls of prescription and over-the-counter drugs in fiscal year 2021 budget legislation.
Rep. Sanford Bishop, D-GA, proposed an amendment to the House fiscal year 2021 Agriculture, Rural Development, FDA and Related Agencies...
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.
