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OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
May 20, 2025
FDA CDER Overview: Certificates of Confidentiality
FDA CDER Overview: Certificates of Confidentiality
May 8, 2025
FDA Pre-Existing Tobacco Product (PTP) Determination Program
FDA Pre-Existing Tobacco Product (PTP) Determination Program
May 7, 2025
FDA CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications
FDA CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications
May 7, 2025
FDA CFSAN Updated “Healthy” Nutrient Content Claim: Final Rule
FDA CFSAN Updated “Healthy” Nutrient Content Claim: Final Rule
April 10, 2025
FDA Generic Drugs Forum 2025
FDA Generic Drugs Forum 2025
April 9, 2025
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
March 13, 2025
Navigating Controlled Correspondences to Support Generic Drug Development
Navigating Controlled Correspondences to Support Generic Drug Development
February 27, 2025
Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development
Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development
February 25, 2025
BsUFA III Regulatory Science Pilot Program: Progress Update
BsUFA III Regulatory Science Pilot Program: Progress Update
January 22, 2025
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