Regulators whipsawed by COVID-19-related drug shortages are seeking better ways to forecast demand.
Preparations for a surge in demand for dexamethasone are already underway in the wake of Oxford University’s announcement on 16 June that the steroid significantly reduced COVID-19 mortality rates in the university’s ongoing RECOVERY trial.
Regulatory authorities, who have seen demand outstrip supply as publicity outpaced the science, and as waves of COVID-19 infections outpaced...
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.
