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FDA invites comments on Expanded Access to Investigational Drugs guidance

USA - November 19 2022 The U.S. Food and Drug Administration (FDA) recently issued a revised version of the draft guidance “Expanded Access to Investigational Drugs for…

Eva Schifini

Seeking harmony: FDA to align its human subject research regulations with Common Rule

USA - November 8 2022 Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject…

William F. Ferreira, Heidi Gertner, Meredith Manning

FDA offers new guidance on charging for investigational drugs

USA - August 24 2022 On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions…

Heidi Gertner

Six strategies for clinical trial & marketing application success as FDA requires HCT/P BLAs

USA - August 13 2022 Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products…

Mike Druckman, Lowell Zeta

FDA outlines rescission of Breakthrough Therapy Designation

USA - June 28 2022 Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,”…

David M. Fox, Lynn W. Mehler