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Federal Register Notice: FDA releases a guidance on drafting warnings and precautions, contraindications, and box warning sections...[ Price : $8.95]
Federal Register Notice: FDA schedules a public workshop 11/29 on data and data needs to advance risk assessment for emerging infe...[ Price : $8.95]
CBER revises its listing of Biological Product Deviation Codes for manufacturers filing a reportable event to FDA.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on appeals of science-based decisions at the Center for ...[ Price : $8.95]
In its latest batch of Warning Letters FDA cites Botanic Oil Innovations and X-Ray Support.[ Price : $8.95]
FDA approves an Edgemont Pharmaceutical NDA for fluoxetine tablets 60 mg, the active ingredient in Eli Lilly's Prozac.[ Price : $8.95]
FDAs Seattle District Office warns X-Ray Support, Inc. about Quality System and registration violations in its manufacturing of de...[ Price : $8.95]
FDA issues a guidance on content and format of specific labeling sections for human Rx drug products and biologicals.