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U.S. Food and Drug Administration Proposes Changes to the Premarket Pathway for Genetic Health Risk Tests

USA - November 10 2017 On Nov. 8, 2017, the Food and Drug Administration (FDA) published two final orders and a notice related to direct-to-consumer (DTC) genetic tests...

Nancy K. Stade.


U.S. Congress Reauthorizes Food and Drug Administration User Fee Programs, Acts on Other FDA Measures

USA - August 15 2017 After more than two years of negotiations and just before the summer recess, the Senate voted to reauthorize the Food and Drug Administration's (FDA)...

Nancy K. Stade, Brigid DeCoursey Bondoc, Coleen Klasmeier.


FDA Considers Removing Regulatory Obstacles to Generic Drug Competition

USA - August 1 2017 On July 18, 2017, the Food and Drug Administration (FDA) held a public meeting1 to obtain input on steps it can take to encourage innovation in drug...

Tina Papagiannopoulos, Coleen Klasmeier.


FDA-Related Issues Not to Miss in the New Cures Legislation

USA - January 10 2017 On Dec. 13, President Obama signed into law the 21st Century Cures Act (Cures). The goal was to “accelerate the discovery, development...

Coleen Klasmeier.


New Guidance Reflects Heightened FDA Focus on Medical Device Cybersecurity

USA - January 26 2016 On January 15, 2016, the Food and Drug Administration (FDA) issued new guidance that, for the first time, recommends routine postmarketing...

Anna L.Spencer, Nancy K. Stade, Tina Papagiannopoulos, Coleen Klasmeier.