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FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations

USA - December 21 2017 On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft guidance stating that the Agency no longer intends to grant...

Chad M. Jennings, John R. Manthei, Amy E. Speros.


FDA Issues Draft Guidance on Biosimilar Interchangeability

USA - January 27 2017 On January 18, 2017, the US Food and Drug Administration (FDA or Agency) issued its highly anticipated draft guidance on demonstrating...

Barrett Tenbarge, J. Benneville (Ben) Haas, Elizabeth M. Richards, John R. Manthei, Eitan N. Bernstein.


FDA to strengthen oversight of certain in vitro diagnostic devices

USA - August 20 2014 On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to strengthen regulation of certain in vitro diagnostics...

Morgan A. Rettig, Stuart S. Kurlander, Esther R. Scherb, J. Benneville (Ben) Haas, Eric Greig.


Unapproved new uses: FDA revisits policies on distributing scientific publications

USA - March 18 2014 On March 3, 2014, the Food and Drug Administration (FDA) released a draft guidance document, “Guidance for Industry: Distributing Scientific and...

John R. Manthei, Shira N. Epstien.


A look at the FDA's new social media guidance

USA - February 13 2014 On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing industry with long-awaited insight into how...

Amy E. Speros.