Read more about the article Clinical Research Update – Lambda Newsletter – June 2024
Clinical Research Updates - June 2024 Newsletter

Clinical Research Update – Lambda Newsletter – June 2024

Regulations, Notices & Guidance June 10, 2024: The FDA announced the "Emerging Drug Safety Technology Meetings; Program Announcement." The Center for Drug Evaluation and Research (CDER) introduced the Emerging Drug…

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Read more about the article Ensuring Data Integrity: FDA’s Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies
Ensuring Data Integrity: FDA's Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies

Ensuring Data Integrity: FDA’s Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies

The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new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.

Continue ReadingEnsuring Data Integrity: FDA’s Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies