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FDA gives Isotechnika Inc. permission to begin the first of two planned Phase 3 kidney transplant trials for its lead product cand...[ Price : $8.95]
Ranbaxy recalls dozens of lots of generic Lipitor after detecting small glass particles in some batches, a move that is likely to ...[ Price : $8.95]
Deka Research and Development Corp. petitions FDA to reclassify stair-climbing wheelchairs from Class 3 to Class 2 devices.[ Price : $8.95]
FzioMed seeks dispute panel resolution of a CDRH decision to deny approval for its PMA for Oxiplex/SP Gel for use in back surgery.[ Price : $8.95]
CDER releases a new policy procedure for handling reviews of grouped chemistry, manufacturing and controls supplements.[ Price : $8.95]
FDA rejects a petition submitted by Natural Resources Defense Council that sought the market withdrawal of products containing lin...[ Price : $8.95]
FDA accepts for review a MAP Pharmaceuticals NDA resubmission for Levadex (dihydroergotamine) inhalation aerosol for treating migr...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance, The Content of Investigational Device Exemption (IDE) and Premarket Approval (PM...