News dal mondo
FDA Issues New and Revised Guidance for Generic Drugs
The US Food and Drug Administration (FDA) on Tuesday released a batch of 21 new and 16 revised draft guidances intended to help drugmakers conduct the studies needed to support the approval of certain generic drugs...[RAPS]
Lonza Completes Capsugel Acquisition
A $5.5 billion acquisition brings Capsugel's oral dosage delivery capabilities to Lonza's portfolio....[PharmTech]
Data Integrity Expectations of EU GMP Inspectors
The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records...[Pharmtech]
Il fondo Principia accelera, 30 milioni per l'azienda farmaceutica Trifarma
L'operatore del venture capital acquisisce il 70% della società lombarda specializzata nella produzione di molecole "intermedie". L'obiettivo...
EMA Defers U.S. GMP Inspections Pending November Activation of Mutual Agreement
The European Medicines Agency is putting off plans for GMP inspections in the U.S. when possible, an EMA spokesperson confirmed this week, in...