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Info Collection Extension for Device PMAs

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Premarket Approval of Medical Devices....

Info Collection Extension on Device Surveillance

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Federal Register notice: FDA sends to OMB an information collection extension for Postmarket Surveillance of Medical Devices 21 C...

FDA Biosimilar Testing Now Faster Than EMA

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Harvard researchers say biosimilars are often approved by FDA before they are approved in Europe.

BlueWillow to Test Intranasal Anthrax Vaccine

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FDA approves BlueWillow Biologics to conduct a Phase 1 study of its next-generation intranasal anthrax vaccine candidate BW-1010.

Public Meeting on Clinical Outcome Assessments Pilot

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FDA announces a 12/5 public meeting on its Standard Core Clinical Outcome Assessments and Endpoints Pilot Grant Program.

More FDA Regulation of Health Apps Needed: Study

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Researchers argue for expanded FDA regulation of health apps to prevent harm to consumers.

FDA Fast Track for Moderna mRNA Drug

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FDA grants Moderna a fast track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia.

FDA Should Regulate Genetic Tests: Disability Council

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The National Council on Disability says FDA and other federal agencies should have active oversight over prenatal genetic testing.

Provention Bio Crohns Trial Misses Endpoint

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Provention Bio says its Phase 2 PRINCE clinical trial evaluating twice-daily Crohns disease drug PRV-6527 showed that the therapy ...

FDA Denies Most of 2 Dopamine Agonist Petitions

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FDA denies most requests in Public Citizen and BioMedEcon petitions seeking stronger labeling and other actions for dopamine agoni...