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EUAs Revoked for 2 Covid Tests

[ Price : $8.95]

Federal Register notice: FDA announces the revocation of the emergency use authorizations issued to Bio-Rad Laboratories for the B...

Product-Specific ANDA Guidances Available

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommenda...

Complete Response on Liver Cancer Combo

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FDA issues Elevar Therapeutics and its Chinese partner, Jiangsu Hengrui Pharmaceuticals, a complete response letter for their comb...

FDA Clears Implicity Heart Failure Algorithm

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FDA clears an Implicity 510(k) for its algorithm SignalHF used in its remote monitoring for heart failure.

Bipartisan Bill on Clinical Trial Participation

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Representatives Raul Ruiz (D-CA) and Larry Bucshon (R-IN) introduce bipartisan legislation to improve participation in clinical tr...

Brainomix Gets Clearance for AI e-Lung Tool

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FDA clears a Brainomix 510(k) for its Brainomix 360 e-Lung for lung imaging.

SCANLY Home Optical Tomography Device Authorized

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FDA grants Notal Vision a de novo authorization for its patient self-operated SCANLY Home optical coherence tomography device.

X4 Pharma Gets Priority Review Voucher

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Federal Register notice: FDA announces the issuance of a priority review voucher to X4 Pharmaceuticals in response to gaining appr...

FDA Qualifies New Ophthalmic Outcome Tool

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FDA qualifies the Assessment of IntraOcular Lens Implant Symptoms patient-reported instrument as a medical device development tool...

Lilly Once-Weekly Insulin Meets Trial Endpoints

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Lilly says its once-weekly insulin efsitora alfa met endpoints in two trials with insulin-nave adults with Type 2 diabetes.