EMA releases draft guidance on risk management in first-in-human clinical trials
The transition from preclinical to clinical step of drug development…
FDA publishes final guidance on non-inferiority trials to establish effectiveness
The non-inferiority design is widely used in clinical trials…
Advantages of clinical trial conduct in countries of CIS region, Georgia and Ukraine
The capacity of countries located in CIS region as with regards…
WHO on biosimilars: changes cannot be done silently!
Changes made to biotherapeutic products and biosimilars…
Biosimilars in the US: lessons learned
The number of Biosimilar Product Development (BPD) programs has…