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FDA finalizes guidance on Orphan Drug “sameness” of gene therapies

USA - October 1 2021 Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting…

Jason F. Conaty, George A. O'Brien, David M. Fox, Gary Veron

FDA and OHRP Finalize Joint Guidance on IRB Meeting Minutes

USA - October 4 2017 The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human…

William F. Ferreira, Heidi Gertner

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

USA - August 21 2017 On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support…

George A. O'Brien, James S. Allred, Robert Church, Mike Druckman, Heidi Gertner, David Horowitz, Bert Lao, Katelyn (Katie) Ruiz Medwid, Gary Veron

The New Hatch-Waxman Regulations: A First Look

USA - November 1 2016 On October 6, 2016, FDA published a final rule implementing portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization…

Robert Church, David M. Fox, Philip Katz, Gary Veron

Finally! FDA Announces Highly-Anticipated and Long-Awaited Public Hearing on “Off-Label” Communications

USA - September 1 2016 In a Federal Register notice published September 1, 2016, the U.S. Food and Drug Administration (FDA) announced a public hearing for November 9-10…

Jennifer Agraz Henderson, Danielle C. Humphrey, Susan S. Lee, Meredith Manning