One-Page MedGuide For Long-acting Opioids Sets Stage For Retooling MedGuide Format
The single-page format could serve as a template as FDA tries to simplify patient information that accompanies prescription drugs.
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FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recommends against approval of Zogenix’s Zohydro ER as it seeks safer formulations and stricter REMS for all extended-release/long-acting opioids.
Oral Contraceptive Labeling Likely To Become More Graphic
FDA is nearing completion of guidance on labeling for combined oral contraceptives with an eye toward improving communication with more visual presentations rather than relying on prose.
Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment
REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.