FDA Issues New Draft Guidances On Cancer Clinical Trial Eligibility Criteria
FDA’s New Draft Guidances on Cancer Clinical Trials Eligibility Criteria
The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new drug applications, new drug applications, and abbreviated new drug applications.
