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Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers

 
• By Derrick Gingery

New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.

FDA entrance sign 2016

The US FDA expects that shared system REMS negotiations should last no more than five months, and dangled the possibility of unilaterally issuing a waiver to the generic sponsor if the talks don't move fast enough.

Two new guidances on single shared system Risk Evaluation and Mitigation Strategies issued May 31 are intended to help eliminate...

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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.