Biologics

9
Dec

FDA PMA and BLA for APLIGRAF and GINTUIT

Class III Medical Device and Biologics License Application (BLA) Class III Medical Device APLIGRAF: P950032 Expedited processing eras authorized on May 30 1995 based on the potential of Apligraf to provide a clinically important advance over existing alternatives in the treatment of chronic venous insufficiency ulcers. Intended Use/Indications Apligraf is indicated for use with standard therapeutic compression for the treatment of non infected partial and full

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16
Feb

Comprehensive Set of Data for FDA IND Trends on Stem Cells

Comprehensive Set of Data for FDA IND Trends on Stem Cells By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 24, 2014   For the first time, a comprehensive set of trended FDA IND data on stem cells is available. The authors have analyzed and compiled “product/CMC, preclinical and clinical information” based on the 66 MSC*-based product

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8
Aug

Oversight of Clinical Investigations A Risk-Based Approach to Monitoring

FDA Guidance for Industry on Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the

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