Overseas Firms Struggle With Software Protocols During U.S. FDA Inspections – Bio Korea
This article was originally published in The Pink Sheet Daily
Compliance with 21 CFR Part 11 of U.S. regulation covering management procedures for software used in clinical trials is at issue.
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Other News from Asia
PharmAsia News looks ahead at 2015 to highlight expected trends and events shaping the biomedical community in Southeast Asia.
Southeast Asia in 2014 saw a continued push by several nations in the region to ink a Trans-Pacific Partnership pact that would potentially have a major impact on biological drugs. Also manufacturing and distribution saw a leap in the hub of Singapore as governments in the region ramped-up health spending.