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FDA Mulls Allowing Links to Risk Info in Social Media Messaging

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FDA considers industry and advertiser proposals to allow links to risk information for promotional activities on character space-l...

Comments Sought on Extending Use of Focus Groups

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Federal Register Notice: FDA asks for comments on an OMB submission seeking an information collection extension on the use of focu...

FDA Docket Established on Patient Partnerships

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Federal Register Notice: FDA establishes a public docket to receive input on a CDRH new program on Patient and Care-partner Connec...

Guidance on IDEs for Neurological Devices

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Federal Register Notice: FDA makes available a guidance on Clinical Considerations for Investigational Device Exemptions (IDEs) fo...

Guidance on Non-inferiority Drug Effectiveness Studies

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FDA posts a guidance on Non-Inferiority Clinical Trials to Establish Effectiveness that discusses the appropriate use of such stud...

FDA Clears EOS Imaging Knee Software

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FDA clears an EOS Imaging 510(k) to market the kneeEOS software, an online 3D planning product software that uses weight-bearing 3...

FDA Approves Pediatric Use of Amgens Enbrel

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FDA approves an Amgen supplemental BLA for the expanded use of Enbrel (etanercept) to treat pediatric patients (ages 4-17) with ch...

FDA/CMS Heads Discuss Changing Evidence Standards

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FDA commissioner Robert Califf and CMS administrator Andrew Slavitt offer their perspectives on the two agencies changing approach...

FDA Guide on MDR Reporting

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FDA releases a final guidance on Medical Device Reporting (MDR) for Manufacturers that is intended to assist manufacturers with me...

FDA Clears 2 Medicrea Pediatric Spinal Devices

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FDA clears two Medicrea Group 510(k)s for its PASSXS posterior fixation and LigaPASSXS band connector components designed to addre...