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FDA Reviewers Question ARS-1 Development Program

[ Price : $8.95]

FDA medical reviewers ask the FDA Pulmonary-Allergy Drug Advisory Committee to consider the adequacy of pharmacokinetic and pharma...

Clinical Hold Lifted on Diarrhea Trials

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FDA removes a clinical hold against two Immuron trials of Travelan, an orally administered passive immunotherapy that prophylactic...

Singlera Breakthrough on Pancreatic Cancer Assay

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FDA grants Singlera Genomics a breakthrough device designation for its PDACatch assay, a DNA methylation-based liquid biopsy assay...

Eyenovias Pupil Dilator Approved by FDA

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FDA approves Eyenovias Mydcombi (tropicamide and phenylephrine HCl ophthalmic spray) for inducing mydriasis for diagnostic procedu...

2-Day Workshop on Generic Research Iniitiatives

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FDA announces a 5/11-12 workshop entitled Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop.

Samsung Irregular Heart Monitor on Watch Cleared

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FDA clears a Samsung Electronics 510(k) for its Irregular Heart Rhythm Notification feature on its Health Monitor app for Samsung ...

De Novo Marketing of 2 Covid Serology Tests

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FDA grants Ortho-Clinical Diagnostics two de novo marketing authorizations for its Vitros Covid-19 serology tests.

Califf Warns of Regulation of Large Language Models

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FDA commissioner Robert Califf warns that large language models (ChatGPT) and their use by industry will require regulation becaus...

FDA Releases Sun Non-compliance Letter

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FDA posts a consent decree non-compliance letter to Sun Pharma outlining inspectional findings at the companys Mohali (Punjab), In...

New Web Page on Antimicrobial Susceptibility Tests

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CDRH launches a new Web page entitled Antimicrobial Resistance and Medical Devices.