Agency’s struggle to meet user fee commitments despite travel restrictions expected to worsen as pandemic continues into 2021.
The US Food and Drug Administration has resumed inspections in China and plans to resume them in India soon as the agency struggles to meet user fee goals during the pandemic, Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said on Twitter on 26 January.
“It has required extensive efforts for FDA to meet user fee goals during the COVID-19 pandemic at a level similar...
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.
