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Court Takes Action Against Edge Pharm

[ Price : $8.95]

A federal court has permanently enjoined a Colchester, VT, compounding pharmacy from distributing drugs unless they are manufactur...

Eko Murmur Smart Stethoscope Software Cleared

[ Price : $8.95]

FDA clears an Eko 510(k) for its Eko Murmur Analysis Software for use in its smart stethoscope for detecting and characterizing mu...

Use Swab Samples of Lesions to Detect Monkeypox: FDA

[ Price : $8.95]

An FDA safety communication advises that testing for monkeypox virus should use swab samples taken directly from a lesion to avoid...

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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