FDA publishes more than 200 archived CRLs for transparency
By disclosing the CRLs, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval.
Regulation
Pharma’s AI prospects get nudged into the future with EU’s AI act
Are regulators keeping pace with AI adoption in clinical trials?
FDA plans to expand unannounced inspections of foreign drug plants
EU Health Data Space strikes a chord in EU harmonisation plans
European agencies catch up with speedier regulatory pathways for CGTs in the US
J&J sues Samsung Bioepis over ‘surreptitious’ breach of Stelara biosimilar contract
EU reshapes HTAs: is the industry ready for it?
