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Elemental Impurities Guidance

[ Price : $8.95]

FDA publishes an International Conference on Harmonization revised guidance on elemental impurities in drug products.

Tavalisses Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rigel Pharmaceuticals Taval...

FDA Investigators Target Pharmaceutical Water Systems

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CDER Office of Manufacturing Quality director Francis Godwin warns that FDA investigators are paying close attention to pharmaceut...

FDA Approves Mallinckrodt Kidney Drug

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FDA approves Mallinckrodts Terlivaz (terlipressin) injection for improving kidney function in certain adults with hepatorenal synd...

Regulatory Review Period for Bulkamid

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Conturas Bulkamid Urethral ...

Affirm Dismissal of Lexapro Case: WLF

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The Washington Legal Foundation says the 2nd Circuit Court of Appeals should affirm a lower courts dismissal of a suit against For...

Rule on Right to Try Act Annual Summaries

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Federal Register notice: FDA issues a final rule specifying the deadline and content for submission of annual summaries under the...

Vanda Sues FDA Over Rejected Hetlioz sNDA

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Vanda Pharmaceuticals files a lawsuit against FDA seeking an order to compel it to publish in the Federal Register a notice of opp...

3 Observations on Aurobindo FDA-483

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FDA releases a form FDA-483 with three observations from an inspection at an Aurobindo active pharmaceutical ingredient manufactur...

FDA Clears Conformis Tapered Hip System

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FDA clears a Conformis 510(k) for its Acter Hip System to add a tri-taper femoral stem design to the device portfolio.