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CDER director Janet Woodcock says a new natural history online tool developed with the National Organization for Rare Diseases can...[ Price : $8.95]
A California Healthcare Institute report sees some improvement in CDRH review times and processes, but says there is still more th...[ Price : $8.95]
FDA notifies Cytori Therapeutics that it can continue enrollment in its ATHENA cardiovascular trials thanks to data and protocol a...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance for tissue establishments and professionals: Same Surgical Procedure Except...[ Price : $8.95]
FDA clears a Centric Medical 510(k) for its Tarsa-Link system for internal bone fixation of fractures, fusions, and osteotomies in...[ Price : $8.95]
MDMA says FDA should not use a draft guidance on 510(k) substantial equivalence decisions to reassess device classifications of pr...[ Price : $8.95]
Rutgers Biomedical and Health Sciences chancellor Brian Strom says an independent advisory committee he chairs encourages drug com...[ Price : $8.95]
FDA approves an Arbor Pharmaceuticals NDA for its Sotylize (sotalol hydrochloride) oral solution, indicated for treating documente...