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Guide on Instructions for Use Patient Labeling

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Instructions for UsePatient Labeling for Human Prescription...

Provepharm NDA for Bludigo Approved

[ Price : $8.95]

FDA approves a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid...

House Urges Senate to Pass User Fee Reauthorization

[ Price : $8.95]

The House Energy and Commerce Committee leadership calls on the Senate to urgently reauthorize FDAs user fee programs.

Hospira Recalls 1 Propofol Lot

[ Price : $8.95]

Hospira recalls one lot of propofol injectable emulsion due to the presence of a visible particulate in a single retained vial fro...

FDA Wants Patient Safety Info on Software Functions

[ Price : $8.95]

FDA solicits comments on software functions excluded from the medical device definition by the 21st Century Cures Act.

Drug Instructions for Use Guidance

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FDA publishes a guidance on the content and format of patient instructions for use documents for prescription drugs and biologics.

Genentechs Enspryng Regulatory Review Period

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Enspryng (satral...

Regulatory Review Period for Glaxos Blenrep

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Blenrep (b...

Summit Considering Additional Ridinilazole Trial

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Summit Therapeutics says it is considering whether to hold at least one more clinical trial of its C. Diff treatment radinilazole ...

Teva Asks Supreme Court to Hear Coreg Skinny Label Appeal

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Teva asks the Supreme Court to hear its appeal of an Appeals Court decision invalidating its skinny label on a generic version of ...