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Latest From Brenda Sandburg
Administration also plans to roll out slate of proposals to decrease drug prices and bring discounts to patients.
IND Safety Reporting: Stakeholders Tussle Over Which Adverse Events To Report, Proper Oversight Body
US FDA officials, drug sponsors discussing creation of library of adverse event rates.
US FDA is considering calls to drop 'totality of circumstances' test and to clarify that mere knowledge of unapproved use does not constitute evidence the use was intended.
Healthcare professionals will be asked about their knowledge of abuse-deterrent opioid formulations along with their views on prescription drug promotions.
Upcoming research projects will look at presentation of FDA approval status, timing of disease awareness ads, and healthcare professional views.