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Violations in Uscom Spirometer Inspection

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FDA warns Uscom Kft about Quality System violations in its illegal manufacturing and marketing of adulterated spirometers at its f...

Hikma Injectables FDA-483 Out

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FDA releases the form FDA-483 with four observations from an inspection at the Dayton, NJ-based Hikma Injectables USA outsourcing ...

Researchers Affirm Mifepristone Safety to FDA

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More than 260 reproductive health researchers urge FDA to continue to support mifepristone based on its 25-year record of safety a...

FDA Looking at MASH Surrogate

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FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Ela...

Grace Therapeutics NDA for Hemorrhage Drug Submitted

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FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subar...

11 QS, MDR Violations at Miach Orthopaedics

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FDA warns Westborough, MA-based Miach Orthopaedics about eight Quality System and three Medical Device Reporting violations in its...

BIO September Congressional Priorities

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The Biotechnology Innovation Organization says its congressional lobbying priorities for September are reauthorization of the FDA ...

Multiple GLP Violations at Chinas Jiangsu Kerbio

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FDA warns Chinas Jiangsu Kerbio Technology Group Co. about its violations of good laboratory practice regulations for nonclinical ...

FDA Breakthrough Status for Lupis Blood Purifier

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FDA grants Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, t...

Inovio Begins Rolling BLA for Rare Throat Disorder

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Inovio Pharmaceuticals begins a rolling BLA submission for INO-3107, an experimental DNA medicine for recurrent respiratory papill...