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CGMP Issues at Indias Apotex Research Private

[ Price : $8.95]

FDA warns Apotex Research Private about recurring CGMP violations at its drug manufacturing facility in Bangalore, India, as well ...

BioSig Tech Gets Pure EP System Cleared

[ Price : $8.95]

FDA clears a BioSig Technologies 510(k) for the Pure EP System, a computerized system intended for acquiring, digitizing, amplifyi...

MolecuLight Gains De Novo Marketing for Wound Imaging

[ Price : $8.95]

FDA grants MolecuLight de novo classification allowing marketing of its wound fluorescence imaging device, the MolecuLight i:X.

More Recalls with 510(k)s Than PMAs: Study

[ Price : $8.95]

Researchers say more recalls occur with foot and ankle medical devices cleared through 510(k)s than approved through PMAs.

FDA Withdraws 20 Unmarketed ANDAs

[ Price : $8.95]

Federal Register notice: FDA withdraws the approval of 20 ANDAs from multiple applicants.

Info Request on DTC Study Sent to OMB

[ Price : $8.95]

Federal Register notice: FDA submits to OMB a new information collection request entitled Experimental Study of Risk Information A...

Paramesh Banerji CGMP Violations

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FDA warns Paramesh Banerji Life Sciences about CGMP violations in its production of finished pharmaceuticals.

Pazdur Explains New Cancer Trial Guidance

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Oncology Center of Excellence director Richard Pazdur solicits stakeholder comments on a new draft guidance on cancer trials using...

FDA Proposes New Diagnostic Test Regulatory Scheme

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Attorney Jeffrey Gibbs outlines provisions advanced by FDA as a new approach to regulating in vitro diagnostics and laboratory-dev...

API Deviations in Yicheng Goto Inspection

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FDA warns Chinas Yicheng Goto Pharmaceuticals about significant deviations of current good manufacturing practice regulations for ...