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FDA Expands Device TAP Pilot

[ Price : $8.95]

FDA expands the medical device Total Product Life Cycle Advisory Program pilot to include the Office of Neurological and Physical ...

Citius Pharma Gets Complete Response Letter

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FDA sends Citius Pharmaceuticals a complete response letter on its BLA seeking approval for Lymphir (denileukin diftitox), indicat...

Abbott Withdraws Trifecta Heart Valves

[ Price : $8.95]

Abbott decides to stop selling its Trifecta heart valves due to the potential risk of early structural valve deterioration.

Info Collection on Combo Product Jurisdiction

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Federal Register notice: FDA requests comments on an information collection extension entitled Product Jurisdiction and Combinatio...

Guide on Biosimilar User Fees

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FDA posts a final guidance entitled Assessing User Fees Under the Biosimilar User Fee Amendments (BUSFA 3) of 2022.

GE Recalls TruSignal SpO2 Sensors

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GE HealthCare recalls its TruSignal SpO2 Sensors due to malfunction issues that may reduce defibrillation energy or expose patient...

FDA, Switzerland Recognizing Each Other's Inspections

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FDA and Switzerland enter into a mutual recognition agreement where each regulatory agency can rely on each others GMP inspections...

FDA, EMA Collaborate on Post-Approval Changes

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Under a new pilot program, FDA and the European Medicines Agency complete the first collaborative assessment of a proposed post-ap...

FDA Not Yet Implementing OTC Drug Reforms: GAO

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A Government Accountability Office review of FDAs over-the-counter drug monograph program performance finds that the agency has no...

Info Collection on Device Improvement Program

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Federal Register notice: FDA sends to OMB a new medical device-related information collection entitled Voluntary Improvement Progr...