FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft ...

The Chinese Food and Drug Administration (“CFDA”) recently announced its first update to the medical device clinical trial guidelines in 12 years. The finalized revision to the 2004 Medical Device ...

This workshop investigates the meaning of Good Clinical Practice (GCP), where it is applicable, and how it differs from other regulations governing clinical research. The focus is on aspects of GCP ...

Unless the norms of Good Clinical Practices in India are harmonized with International Council of Harmonization (ICH), Indian companies would find it difficult to cope with demands of future global ...