US FDA’s reorganization of its inspection office will also showcase efforts to enhance the agency’s IT infrastructure. But Commissioner Califf is warning the agency’s ‘digital transformation’ efforts could still fall victim to internal silos and external pressures to ‘divide and conquer.’
The US Food & Drug Administration’s reorganization of its inspectional functions will also be a testing ground for the agency’s “Digital Transformation” efforts.
FDA unveiled its reorganization plan for the Office of Regulatory Affairs, which will be renamed the Office of Inspections &...
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.
