ICH Q12 toolbox and change management
FDA releases final guidance for upcoming biological product transition
Coronavirus: Emergency planning for the drug supply chain
FDA swears in Dr Stephen Hahn as new Commissioner
FDA conducts NDMA testing on stomach acid medication
Orphan drug success is changing the sector
Biotin technology under pressure following FDA warning to lab staff
PDA and ISPE publish guide to finding root cause of quality failure
FDA partners with university on biopharmaceutical manufacturing
FDA approves nine companies for first generics of Lyrica
FDA leadership is a three horse race
GMP inspection in Bulgaria and Cyprus now on par with US
Dr Norman Sharpless has big shoes to fill as new Acting FDA Commissioner
FDA criticises supplier qualification in warning letter to Vilvet
Cyborg technology draws FDA attention
