Search Results for: Risk Management

Implementation of Consistent Language as Outlined in FDA Draft Guidance on Drug Abuse and Dependence Labeling Will Support Drug Development, Labeling and Prescriber Decision-Making

By Jack Henningfield, Karen Gerlach, Judy Ashworth, Marion Coe, Sid Schnoll Once finalized, FDA Draft Guidance “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format” will help ensure more consistent language across drug products about abuse, misuse, addiction, dependence, and tolerance. Our experts in the development... Read more »... Read More >

Opana ER: What other questions could have been asked?

PA experts observing the recent marketing withdrawal of Opana ER (oxymorphone hydrochloride) considered other data that could be examined to determine if there is something inherent to the formulation that encourages more dangerous avenues of abuse, and the impact of other external factors on real-world safety. On July 6, Endo Pharmaceuticals announced it would withdraw... Read more »... Read More >