If the US FDA could track production, it could anticipate shortages – and national security threats from countries like China.
Real-time tracking of pharmaceutical manufacturing volume would go a long way toward helping the US Food and Drug Administration better anticipate drug shortages and drug-related national security risks, Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, told Congress 30 October.
However, such tracking would require legislation, she told a House Energy and Commerce Health Subcommittee hearing, because as it stands...
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.
