Search
Sharan Murugan
- Jun 15
- 2 min
USFDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
The US Food and Drug Administration (FDA) released the final guidance yesterday (14 June 2024) titled "Clinical Pharmacology...
17 views0 comments
Sharan Murugan
- Mar 5
- 2 min
USFDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
18 views0 comments
Sharan Murugan
- Dec 19, 2023
- 2 min
USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices
Recently (14 December 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...
10 views0 comments