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FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations

USA - December 21 2017 On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft guidance stating that the Agency no longer intends to grant...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

FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding

USA - August 9 2017 On August 3, 2017, the Senate passed the Food and Drug Administration Reauthorization Act (FDARA or the Act) by a vote of 94-1.1 The FDARA bill had...

Morgan A. Rettig, Nathan A. Beaton, Elizabeth M. Richards.

FDA Works to Increase Competition Under Commissioner’s Drug Competition Action Plan

USA - June 29 2017 In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps under FDA Commissioner Scott Gottlieb’s Drug...

Adam M. Susser, J. Benneville (Ben) Haas.

FDA Issues Draft Guidance on Biosimilar Interchangeability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January 27 2017 On January 18, 2017, the US Food and Drug Administration (FDA or Agency) issued its highly anticipated draft guidance on demonstrating...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, Carolyne R. Hathaway, Eitan N. Bernstein.

President Obama Signs the 21st Century Cures Act Into Law

USA - December 13 2016 On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), which Congress passed with strong bipartisan support...

Morgan A. Rettig, Nicole A. Liffrig Molife, Stuart S. Kurlander, J. Benneville (Ben) Haas, Eric Greig, Daniel Meron, Susan Ambler Ebersole.