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Time and Extent Applications Guidance

[ Price : $8.95]

FDA publishes a guidance on information needed in an application to include a drug in the OTC monograph system.

FDA Warns Against Illegal LASIK Ads Again

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FDA threatens eye care professionals with regulatory action against inappropriate advertising and promotion of refractive procedur...

Quality Problems Cited in Korean Medical Device Firm

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FDA warns South Koreans Bionet about Quality System violations in its manufacturing of monitoring and analysis systems.

Guidance on User Fee Waivers

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Federal Register Notice: FDA releases a guidance on requests for user fee waivers and reductions or refunds.

Quality Problems Found in Sichuan APIs

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FDA warns Sichuan Pharmaceutical of CGMP deviations at its Chinese API manufacturing facility.

Treanda Records Subpoenaed

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A New York U.S. attorney subpoenas records from Cephalon on its Treanda cancer drug.

FDA Accepts Marqibo NDA for Leukemia

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FDA accepts for filing a Talon Therapeutics NDA seeking accelerated approval for Marqibo (vincristine sulfate liposomes injection)...

FDA Clears Titan Spinal Fusion Device

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FDA clears a Titan Spine 510(k) for its Endoskeleton TAS system, an anterior lumbar interbody fusion device with integrated fixati...

FDA 'Orphan' Status for PAH Drug

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FDA grants Tarix Pharmaceuticals orphan drug status for TXA127, the company's lead peptide drug candidate being evaluated for trea...

FDA Approves Calypso IDE for Lung Cancer Study

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FDA approves a Calypso Medical Technologies IDE for a clinical study evaluating real-time tracking of lung cancer tumors during ra...