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FDA Webview posts the court-approved 8/30 Janssen Pharmaceuticals settlement where the company agreed to pay $181 million to 37 st...[ Price : $8.95]
Noven asks FDA to require specific tests for any sponsor submitting an ANDA for generic Daytrana transdermal system.[ Price : $8.95]
A Louisiana federal judge rules that a state law case involving failure-to-warn of risks with generic Reglan is preempted by feder...[ Price : $8.95]
Bayer HealthCare submits an NDA for regorafenib, an oral multi-kinase inhibitor for treating metastatic or unresectable gastrointe...[ Price : $8.95]
FDA tells Exelixis that its NDA for cabozantinib, which is seeking an indication for treating patients with progressive or metasta...[ Price : $8.95]
FDA approves Ironwood and Forests Linzess for treating chronic idiopathic constipation and irritable bowel syndrome with constipat...[ Price : $8.95]
A CDRH and Advanced Medical Technology Association joint workshop offers best practices advice for reporting changes associated wi...[ Price : $8.95]
Federal Register Notice: FDA withdraws an obsolete Compliance Policy Guide Sec. 420.300 Changes in Compendial Specifications and N...