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FDA Regulatory Review Period for Ionsys is 4,835 Days

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Federal Register Notice: FDA determines that 4,835 days is the regulatory review period for a Medicines Company NDA for Ionsys (fe...

Senators Want Mylan DoJ Probe

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Three senators ask the Justice Department to investigate whether Mylan deliberately misclassified its EpiPen as a non-innovator dr...

80% of Chinese Trial Data Fabricated: SFDA Report

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A one-year study by Chinese drug regulators finds massive fabrication of clinical trials data for drugs awaiting marketing approva...

FDA, Athersys Agree on Special Protocol for Cell Therapy

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FDA and Athersys reach agreement on a special protocol assessment for the design and planned analysis of a Phase 3 clinical trial ...

FDA Updates Expedited Access Pathway Web Site

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FDA adds two Expedited Access Program Data Development Plan examples to its Web site to give formatting suggestions to sponsors.

FDA Accepts BLA for Romosozumab in Osteoporosis

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FDA accepts for review an Amgen and UCB BLA for romosozumab, an investigational monoclonal antibody for treating osteoporosis in p...

CDER Seeks Translational Sciences Deputy Director

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CDER conducts a nationwide search for the permanent position of Office of Translational Sciences deputy director for science as cu...

FDA Approves Medtronics Artificial Pancreas

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FDA approves Medtronics MiniMed 670G hybrid closed looped system, the first agency-approved device or artificial pancreas that is ...

FDA OKs Abbotts FreeStyle Continuous Glucose Monitor

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FDA approves an Abbott PMA for the FreeStyle Libre Pro system, a continuous glucose monitoring system for healthcare professionals...

Adaptive Design Guidance Explained

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CDRH and CBER officials discuss a final guidance on adaptive clinical trial designs in an agency webinar.