[ 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...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance, Vaginal Microbicides: Development for the Prevention of HIV Infection.[ Price : $8.95]
Federal Register Notice: FDA posts a Web site location for FY 2013 planned CDRH guidance documents.