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Federal Register Notice: FDA releases a draft guidance on the submission of warning plans for cigarettes and smokeless tobacco pro...[ Price : $8.95]
An FDA advisory committee reviews safety issues associated with the long-term use of bisphosphonates for treating and preventing o...[ Price : $8.95]
Sagene Pharmaceuticals completes a pre-IND meeting with CDER reviewers to discuss the development plan for SPI-1972, a dual-action...[ Price : $8.95]
Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 11/2 to discuss Merk/Schering-Plough...[ Price : $8.95]
Nexera Medical says it plans to submit an amended 510(k) for the SpectraShield 9500 Surgical N95 Respirator for expanded antimicro...[ Price : $8.95]
A CDRH letter to industry provides recommendations to help ease the FDA import entry review process for medical and non-medical ra...[ Price : $8.95]
An FDA advisory committee votes to recommend approval of a Janssen Pharmaceuticals NDA for its investigational drug Xarelto (rivar...[ Price : $8.95]
NeurogesX files a supplemental NDA seeking to expand the label for Qutenza (capsaicin) 8% patch to include an indication for manag...