House Republicans keep the pressure on the US FDA for plans to catch up on inspections after the long COVID-19 hiatus. Recent cancer drug shortages could be a headline event to lead into a larger probe.
The House Energy and Commerce Committee Republican leadership is asking the US Food and Drug Administration for a wealth of information about its approach to inspections in India and China coming out of the COVID shutdown period.
A July 18 letter to Commissioner Robert Califf focuses squarely on a key vulnerability for the agency: how to...
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.
