BE/BA sites must be logged with US FDA under GDUFA
CROs conducting bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.
Archives for August 27, 2012
United Drug buys DSA and Synpoia
United Drug (UD) has bought firms in the pharmacovigilance and market access sectors, following up on its acquisition in the contract packaging industry last week.
Delivery tech deals for Depomed, Silence and funding for Micropoint
New developments in the delivery space with Depomed signing up another Big Pharma licensee, Silence teaming up to test its tech for MiReven and Micropoint securing development funds for its microneedle system.
UPDATE
NHS announces plans to become international healthcare provider
The UK’s National Health Service (NHS) has launched plans to provide services to the pharmaceutical industry internationally.
Market access teams should have more influence in clinical trial design, say Cutting Edge Information
Health economics and outcomes research teams must have a greater influence over clinical trial design if pharma firms are to achieve reimbursement goals, according to Cutting Edge Information.
Pfizer calls on Mylan to make generics for Japan
Mylan will manufacture Pfizer’s generic drugs for the Japanese market under a new collaboration.
Bosch launches"future-proof" filling tech
Bosch packaging has launched two new capsule filling machines which it says are capable of handling all current and future applications.