Xtampza ER Warnings Can't Be Hidden Behind Table And Chairs, US FDA Tells Collegium
OPDP's first enforcement letter of 2018 is notable because it comes much earlier than 2017's first, cites an opioid, and signals that the US FDA is monitoring medical meetings.
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Collegium, BioDelivery To Combine Pain Portfolios In Proposed Merger
Collegium has offered a 54% share premium to acquire competitor BioDelivery, in an offer approved by both firm’s boards. The $604m price tag would double the size of Collegium’s product portfolio.
US FDA Actions On Rx Drug Promos Covered New Territory Last Year
Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.
How Should US FDA Navigate Thorny First Amendment Conundrums: Former Chief Counsels Offer Advice
Daniel Troy suggests FDA increase its investment in science of consumer understanding, while Richard Cooper recommends the "bully pulpit" approach to get industry's attention. A panel of former chief counsels stressed that the agency cannot continue to ignore First Amendment free speech issues.