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FDA Resumes Generic Drug In-person Meetings

[ Price : $8.95]

FDA says that it is now resuming generic in-person face-to-face meetings with generic drug industry members in a phased-in approac...

Alternative 510(k) Pathway for Contact Lenses

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FDA makes available a final guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety and Pe...

Vaporox Next-gen Wound Healer Cleared

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FDA clears a Vaporox 510(k) for its next-generation VHT-200 medical device system for healing chronic wounds.

Iovance Biotherapeutics BLA for Melanoma Therapy

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Iovance Biotherapeutics files a rolling BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating certai...

Draft Guide on Cancer Drug Accelerated Approvals

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Federal Register notice: FDA posts a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Onco...

OTC Monograph Drug User Fee Rates

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Federal Register notice: FDA announces the fee rates under the over-the-counter monograph drug user fee program for fiscal year 20...

Two Final Guides on Covid-19 Device Transition

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FDA issues two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizat...

Accelerated Approval Guide Pushes Randomized Trials

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Pushing randomized clinical trials, FDA issues a draft guidance entitled Clinical Trial Considerations to Support Accelerated Appr...

CDER/CBER Digital Health Framework

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Federal Register notice: FDA releases CDER/CBERs Framework for the Use of Digital Health Technologies in Drug and Biological Produ...

Cell/Gene Therapy Post-approval Data Meeting

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CBER's Office of Therapeutic Products plans a 4/27 public listening meeting to obtain feedback on methods and approaches for captu...