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FDA says it is funding a collaborative agreement with the World Health Organization to develop global counterfeit/falsified drug s...[ Price : $8.95]
CDER issues three MAPPs on how staff are to solicit all relevant opinions and resolve professional differences in Center decision-...[ Price : $8.95]
New CDRH Office of Compliance (OC) director Steve Silverman tells an industry conference that his office is taking aim at recalls ...[ Price : $8.95]
Office of Regulatory Affairs Office of Enforcement director Howard Sklamberg tells FDLI that Warning Letters shot up 25% in FY 201...[ Price : $8.95]
FDA says more clinical studies are needed for Jazz Pharmaceuticals NDA for JZP-6 to treat fibromyalgia.[ Price : $8.95]
FDA asks for more information and further testing for Alexzas inhalation aerosol Adusuve Staccato, proposed for rapid treatment of...[ Price : $8.95]
FDA reaches agreement with ArQule, Inc. on a special protocol assessment for the design of a Phase 3 trial of ARQ 197 in patients ...[ Price : $8.95]
FDAs Neurological Devices Panel has a hard time advising FDA on issues relating to clinical trials of devices to treat depression....