jueves, 11 de septiembre de 2025
Development of Non-Opioid Analgesics for Chronic Pain Draft Guidance for Industry September 2025 +++
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-chronic-pain
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
September 2025
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other-quality
E6(R3) Good Clinical Practice (GCP)
September 2025
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp
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