FDA’s GMP Expectations — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials

Manufacturing an investigational product for the initial pilot clinical trials can be a complex and costly endeavor for developers. These first-in-man and pilot clinical trials, usually conducted with a small number of healthy participants, are primarily aimed at establishing safety. Therefore, they do not require a significant amount of investigational material. Recognizing this, the US FDA allows developers to test early-stage investigational products under relaxed GMP requirements.

Topics: FDA, Gmp, Clinical Trials, FDA Regulations, FDA Compliance,