US FDA inspections lead to warning letters for Aurobindo and Health Plus, while Emergent BioSolutions site escapes nearly unscathed; Sun waits for Halol revisit and Jubilant suffers poor-quality costs as agency investigators resume domestic surveillance post-omicron.
As US Food and Drug Administration investigators venture out more, there will be new opportunities for drug manufacturers to show off the quality systems that have been carrying them through the pandemic relatively unobserved.
With the wave of omicron variant COVID-19 infections declining steeply in the US, the FDA this week resumed domestic surveillance...
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.
