Limits On Pediatric Exclusivity And DTC Advertising Stripped From FDA Bill During Subcommittee Markup
This article was originally published in The Pink Sheet Daily
Executive SummaryFull Committee Chairman Dingell joins many Democrats in voting to establish civil fines and a pre-submission requirement for TV ads instead of the potential three-year moratorium set out in the draft bill.
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In the absence of sunset provisions that necessitate periodic reauthorization of the pediatric laws, GAO would report to Congress on a five-year cycle about the accomplishments of the drug programs for children and make recommendations for amendments.