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The US Food and Drug Administration (FDA) has issued draft guidance outlining the clinical pharmacology considerations for human radiolabeled mass balance studies for investigational...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The US Food and Drug Administration (FDA) issued draft guidance documents on drug development for ulcerative colitis (UC) and Crohn’s disease, outlining recommendations on...

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...

USA – Industry guidance aims to help manufacturers adhere to bar coding requirements

The Healthcare Distribution Alliance (HDA) on Monday issued a guide to help the pharmaceutical industry in formatting and placing bar code labels on their products to...

USA – Celiac disease: FDA offers guidance on drug development

The US Food and Drug Administration (FDA) on Friday issued a draft guidance to industry on developing drugs or biologics to treat celiac disease (CeD) as...

USA – FDA offers guidance on waiver requests for pH adjusters

The US Food and Drug Administration (FDA) has issued a draft guidance on its criteria for permitting the use of pH adjusters in parenteral, ophthalmic or...

USA – FDA finalizes guidance on drug bioavailability studies

The US Food and Drug Administration (FDA) has published a final guidance on the bioavailability (BA) data drug sponsors should include in their premarket...

USA – FDA recommends sponsors plan to include race, ethnicity in clinical trial design

The US Food and Drug Administration (FDA) is recommending sponsors include a plan to increase diversity when proposing clinical trial designs for investigational products...

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