USA – FDA offers insight into product quality assessment principles
The US Food and Drug Administration (FDA) has issued draft guidance outlining its benefit-risk principles when evaluating product quality assessments for new drug applications...
USA – FDA sheds light on conducting human radiolabeled mass balance studies
The US Food and Drug Administration (FDA) has issued draft guidance outlining the clinical pharmacology considerations for human radiolabeled mass balance studies for investigational...
USA – FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease
The US Food and Drug Administration (FDA) issued draft guidance documents on drug development for ulcerative colitis (UC) and Crohn’s disease, outlining recommendations on...
