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Jun 152 min read

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...

Mar 52 min read

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...

Dec 19, 20232 min read

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...