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The FDA is faulting a clinical investigator for neglecting to follow the established procedures for a trial testing a new investigational drug. Read More
Celator Pharmaceuticals has received a drug enforcement promotion letter as a result of a drug it showcased during the annual meeting of the American Society of Clinical Oncology (ASCO). Read More
The FDA intends to clarify its expectations for demonstrating the interchangeability of biosimilars with reference products, an FDA official said. Read More
When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance. Read More