US FDA Needs ‘More Streamlined’ REMS Enforcement Authority, Inspector General Says

 
• By Derrick Gingery

Additional power would allow the agency to punish 'simple' REMS violations and improve administration of risk management programs, according to a new report looking at FDA's oversight of opioids.

Concept image of Business Acronym IG as Inspector General written over road marking yellow paint line.
The HHS OIG also called for mandated opioid prescriber training through the REMS, but the FDA disagreed. • Source: Shutterstock

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