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USFDA Guidance: Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
The U.S. Food and Drug Administration (FDA) has issued Revision 1 of its guidance titled "Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations" (May 2026), prepared by the Office of Clinical Pharmacology within the Center for Drug Evaluation and Research (CDER). This revision supersedes part of the 2022 guidance on Food-Effect Bioavailability and Fed Bioequivalence Studies and consolidates current FDA thinking on when, why, and how fo
Sharan Murugan
May 204 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...
Sharan Murugan
Jun 15, 20242 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...
Sharan Murugan
Mar 5, 20242 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...
Sharan Murugan
Dec 19, 20232 min read