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The US Food and Drug Administration (FDA) issued draft guidance documents on drug development for ulcerative colitis (UC) and Crohn’s disease, outlining recommendations on...
USA – FDA finalizes electronic postmarketing safety reporting guidance
The US Food and Drug Administration (FDA) has finalized guidance that outlines how postmarketing safety reports for drugs and biologics should be submitted electronically....
USA – FDA finalizes guidance for drugs and biologics containing nanomaterials
The US Food and Drug Administration (FDA) has released its final guidance for industry on human drug and biological products that contain nanomaterials.
Initial draft...
USA – Extrapolation of drug indications from study populations by FDA is ‘common’
Extrapolation of indications in new drug approvals by the US Food and Drug Administration (FDA) to populations not originally studied in pivotal clinical trials...
