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Federal Register Notice: FDA sends a proposed collection of information on requirements for device establishments to register and ...[ Price : $8.95]
FDA approves an Akorn ANDA for a generic copy of Alcons Ciloxan.[ Price : $8.95]
FDA accepts a Merck supplemental NDA for Isentress (raltegravir) tablets, seeking approval for the drugs combination use with othe...[ Price : $8.95]
Reps. Barton and Shimkus ask questions about a $1.5 million FDA contract to improve morale in the CDER drug safety staff.[ Price : $8.95]
FDAs Obstetrics and Gynecology Devices Advisory Committee says the Female Health Co.s FC2 female condom is approvable.[ Price : $8.95]
FDA approves Schering-Ploughs Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy for use in previously ...[ Price : $8.95]
Genta says it intends to appeal FDAs recent decision not to approve an amended NDA for Genasense, indicated for combination use wi...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on submission and review of sterility information in 510 (k) submissions fo...