If agency has concerns about facilities it cannot inspect, it will generally issue complete responses, Q&A guidance says.
The US Food and Drug Administration confirmed in a 19 August guidance document that it will generally issue complete response letters to sponsors when it has concerning information about the manufacturing facilities listed in their product marketing applications but cannot conduct a timely pre-approval inspection, or PAI, due to the pandemic.
Alternatively, the agency said if it lacks adequate information to decide whether a facility is acceptable, it may defer action...
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.
