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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...

Anna K. Sims, Torrey Cope.


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, Torrey Cope.


U.S. Food and Drug Administration Announces New Tobacco Policies Acknowledging the Role of Harm Reduction

USA - August 8 2017 On what should have been a quiet Friday in late July, the Food and Drug Administration (FDA) revealed a number of new policies, representing arguably...

Deepti A. Kulkarni, Brigid DeCoursey Bondoc, Parker D. Kasmer.


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, Torrey Cope.


FDA Delays Effective Date of Its Aggressive Final Rule on Intended Use

USA - April 4 2017 On March 20, 2017, FDA announced a further delay of the effective date of its January 9, 2017, Final Rule entitled Clarification of When Products...

Charlene Cho.