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Late Petitions Cant Delay ANDA Approval

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FDA says a final rule taking effect 1/9/17 aims to prevent late citizen petitions or petitions for a stay of action from delaying ...

Firm Compounding Unapproved Domperidone Product: FDA

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FDAs San Francisco District Office warns Innovative Compounding Pharmacy about CGMP violations in its compounding of unapproved do...

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...