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Federal Register Notice: FDA releases a guidance: Providing Regulatory Submissions in Electronic Format Submissions Under Section...[ Price : $8.95]
Federal Register Proposed rule: FDA proposed to amends is prescription drug and biological product labeling regulations to require...[ Price : $8.95]
FDA issues Hovione a Form FDA-483 after conducting a pre-approval inspection at its plant in Loures, Portugal, covering two NDA fi...[ Price : $8.95]
The Generic Pharmaceutical Association gives FDA officials an alternative proposal for making safety changes to generic drug label...[ Price : $8.95]
FDA commissioner Margaret Hamburg congratulates CDER director Janet Woodcock on receiving the Institute of Safe Medication Practic...[ Price : $8.95]
HDMA asks FDA to exercise enforcement discretion for at least three months after the 1/1/15 implementation date for data transfer ...[ Price : $8.95]
Veloxis Pharmaceuticals files suit against FDA seeking an order requiring the agency to grant final approval to Envarsus XR (tacro...[ Price : $8.95]
FDA accepts for review an Apotex submission for a biosimilar version of Amgens Neulasta (pegfilgrastim), indicated for boosting wh...