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FDA posts a final guidance on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Produc...[ Price : $8.95]
A Delaware federal district judge says Hospira can sell a generic form of Cubists Cubicin after one upheld patent expires in 2016....[ Price : $8.95]
Some 51 organizations ask FDA to withdraw its proposed guidance on laboratory-developed tests and proceed through notice and comme...[ Price : $8.95]
Harvard Law student Zachary Shapiro says states should consider approving a DTC exception to the learned intermediary rule to forc...[ Price : $8.95]
FDA clears a Focus Diagnostics 510(k) for the Simplexa Flu A/B & RSV Direct Kit for testing for eight additional influenza strains...[ Price : $8.95]
CDRH director Jeffrey Shuren calls on many stakeholders to adopt the medical device unique device identifier as a means of improvi...[ Price : $8.95]
Federal Register Notice: FDA corrects an incorrect docket number in an 8/1 notice on the generic clearance for the collection of q...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: General Clinical Pharmacology Considerations for Pediatric Studies for Dru...