A bipartisan group of lawmakers is concerned about the growing number of recalls of blood pressure medicines from foreign manufacturing sites in China and India and wants answers from GAO and FDA.
Members of Congress are concerned about the rising number of recalls of blood pressure medications and are asking the US Food and Drug Administration and the General Accountability Office for information on the agency's foreign inspection program. They are concerned that the agency may lack the resources and management practices to adequately oversee foreign inspections.
These concerns also stem from recent media reports that the FDA’s field inspection staff and managers at the FDA’s Center...
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.
