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Recent FDA Enforcement Letters Lay Out Roadmap for Future Scrutiny of Efficacy Claims

USA - October 23 2018 The U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently released the third untitled letter in 2018 to...

Coleen Klasmeier, Anna K. Sims.


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)...

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


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...

Coleen Klasmeier, Tina Papagiannopoulos.


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.