Komal A. Karnik
Hogan Lovells
Articles
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…
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…
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
