Hamburg Gives Rallying Cry For FDA Power In Her Public Farewell
This article was originally published in The Tan Sheet
The outgoing commissioner gives forceful defense of the agency’s regulatory authority and warns that lowering drug approval standards would damage patients and industry.
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Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.
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