FDA will have completed capability assessments for eight European Union member country inspectorates by that time, with all 28 to be completed by mid-2019; EU assessment of US regulator’s inspection capabilities wraps up in July.
The US FDA will start recognizing drug manufacturing facility inspections conducted by certain European Union member states in November under the US/EU mutual recognition agreement.
“In November of this year, we will recognize inspections of … countries that we’ve determined to be capable,” Dara Corrigan,...
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.
