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Woodcock Sees Clinical Trials Deteriorating Under Covid

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CDER director Janet Woodcock says the Covid-19 pandemic has led to a further deterioration in the U.S. clinical trials system.

Qualitative Data Collection on Tobacco Products

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Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for the Collection of Qua...

Cardio/Renal Drugs Panel Charter Extended

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Federal Register notice: FDA announces the renewal of its Cardiovascular and Renal Drugs Advisory Committee for an additional two ...

CGMP Violations at Panacea Biotec

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FDA warns Indias Panacea Biotec about CGMP violations in its production of finished drugs.

Intrathecal Compounding Specialist Inspection Violations

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FDA warns Intrathecal Compounding about deficiencies in its production of sterile drugs.

Breast Implant Labeling Guidance

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FDA issues a guidance on the content and format for some labeling information for breast implants.

Blood Glucose Monitoring Test Systems Guidance

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Federal Register notice: FDA announces the availability of a final guidance on Blood Glucose Monitoring Test Systems.

Clinical Trial Guide on Covid-19 Symptoms

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Federal Register notice: FDA makes available a final guidance on assessing Covid19-related symptoms in clinical trials.

Guide on Gaining Final ANDA Approval

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Federal Register notice: FDA makes available a final guidance entitled ANDA Submissions Amendments and Requests for Final Approva...

Meeting on Systemic Sclerosis Patient Perspectives

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FDA announces a 10/13 virtual public meeting on Patient-Focused Drug Development for Systemic Sclerosis to obtain patients perspec...