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Bipartisan Bill on Clinical Trial Participation

[ Price : $8.95]

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

[ Price : $8.95]

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.

FDA Updates Covid-Related Device EUAs

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Federal Register notice: FDA announces the issuance of emergency use authorizations (EUAs) for certain medical devices related to ...

FDA Publishes 32 New Product-Specific Guidances

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FDA publishes 32 new and revised product-specific guidances to aid in development of generic drugs and a revised list of PSGs unde...

Breakthrough Status for Karius Test

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FDA grants Karius a breakthrough device designation for its Karius Test for use in the diagnosis and management of immunocompromis...

Clarify Animal Testing Rules: Humane Society

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The Humane Society of the U.S. petitions FDA to take actions to inform drug developers and sponsors that they are not always requi...

Group Urges $200 Million Boost in FDA Funding

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The Alliance for a Stronger FDA urges Congress to provide FDA with $3.9 billion in budget authority for fiscal year 2025, which is...

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...