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FDA says it is requiring Warnings on labels of general anesthetics and sedation drugs about the risk of childrens brain developmen...[ Price : $8.95]
Attorney James Beck says that preemption of state law failure-to-warn claims applies to OTC drugs in many instances, in the same w...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion says a Sanofi TV ad for Toujeo makes false or misleading representations about the dru...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion says that a Celgene TV ad for Otezla undermines communication of important risk inform...[ Price : $8.95]
FDA selects Department of Justice Office of International Affairs attorney Donald D. Ashley as CDERs next Office of Compliance dir...[ Price : $8.95]
FDA finalizes a guidance on Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals) that describes CD...[ Price : $8.95]
A CDRH conference call clarifies when medical device firms are required to file Medical Device Reporting submissions and answers q...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a new information collection related to Donor Risk Assessment Questionnaire for FDA...