FDA Vioxx Documents Offer Case Study For “Drug Watch” Website
The discussions between Merck and FDA regarding the best way to present safety data from the VIGOR trial in Vioxx labeling offer a case study in how the agency's new "Drug Watch" safety website may affect disclosure of risk information
You may also be interested in...
HHS is planning a major overhaul of FDA's postmarketing surveillance system as the centerpiece of its next announcement about upgrades to the drug safety regulatory system
The Vioxx labeling change will allow Merck to discuss the COX-2 inhibitor's cardiovascular safety profile in the context of a rheumatoid arthritis indication and a gastrointestinal safety benefit
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011