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BsUFA III Regulatory Science Pilot Program: Progress Update
BsUFA III Regulatory Science Pilot Program: Progress Update
January 22, 2025
FDA Clinical Investigator Training Course (CITC) 2024
FDA Clinical Investigator Training Course (CITC) 2024
December 10, 2024
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance
November 21, 2024
Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation
Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation
November 7, 2024
Global IDMP Implementation – Getting Closer to the Goal
Global IDMP Implementation – Getting Closer to the Goal
October 16, 2024
ICH M12 Drug-Drug Interaction Studies Final Guidance
ICH M12 Drug-Drug Interaction Studies Final Guidance
October 9, 2024
Advancing Generic Drug Development: Translating Science to Approval 2024
Advancing Generic Drug Development: Translating Science to Approval 2024
September 24, 2024
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
September 12, 2024
FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
September 4, 2024
Environmental Monitoring in Compounding
Environmental Monitoring in Compounding
July 30, 2024
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