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Opioid Policy At US FDA: Over-Promising Or Overreacting?

 
• By Michael Cipriano

As President Trump signs SUPPORT Act, former FDA chief counsels offer dueling interpretations of agency's impact in combating opioid crisis.

Skull-shaped pills in Halloween colors
• Source: Cindy Shebley

President Trump signed into law Oct. 24 the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act that gives the US FDA new authorities to tackle the opioid crisis, exemplifying a potential conundrum of whether the agency is over-promising or overreacting on the epidemic.

Richard Cooper, who served as FDA chief counsel from 1977 to 1979, questioned whether FDA Commissioner Scott Gottlieb has set...

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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.