FDA Review and Approval Process for Biosimilar Medications

FDA Review and Approval Process for Biosimilar Medications
Share:

Download MP3


Similar Tracks

PFDD Workshop to Discuss Methodologic & Other Challenges Related to Patient Experience Data – Part 2 U.S. Food and Drug Administration
FDA Clinical Investigator Training Course (CITC) 2024 (Day 1 of 3) U.S. Food and Drug Administration
PFDD Workshop to Discuss Methodologic & Other Challenges Related to Patient Experience Data – Part 1 U.S. Food and Drug Administration
FDA Perspectives on Biosimilar BLA-Manufacturing (28of33) Quality – Oct. 16-17, 2019 U.S. Food and Drug Administration
Regulatory Highlights for Biosimilars and Interchangeables (9of15) REdI – May 29-30, 2019 U.S. Food and Drug Administration
FDA FY2025 Small Business Fair U.S. Food and Drug Administration
The Basics of Biosimilars U.S. Food and Drug Administration
PFDD Workshop to Discuss Methodologic & Other Challenges Related to Patient Experience Data – Part 3 U.S. Food and Drug Administration
How Biomarkers Can Improve the Drug Development Process U.S. Food and Drug Administration
Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020 U.S. Food and Drug Administration
Ovarian Cancer: Moving to a Personalized Treatment Approach U.S. Food and Drug Administration
Data Requirements for Biosimilars U.S. Food and Drug Administration
Importing FDA-Regulated Products: The Import Process U.S. Food and Drug Administration
Cannabis Products and the Potential Impact on Patients U.S. Food and Drug Administration
Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance 2020 U.S. Food and Drug Administration
Clinicians Connect: Conversations w/ FDA's CMO on reducing cases of congenital syphilis & syphilis U.S. Food and Drug Administration
Components of New Drug Application and Biologics License Application (5of15) REdI– May 29-30, 2019 U.S. Food and Drug Administration
Biosimilars: Critical Quality Attributes U.S. Food and Drug Administration
How does the FDA approve new drugs? U.S. Food and Drug Administration
National Drug Code (NDC) for Healthcare Providers U.S. Food and Drug Administration