Category Archive: FDA Regulatory Guidances

Jan 04

New FDA Guidances for December 2018

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in December are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Labeling of Red Blood Cell Units with Historical …

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Dec 11

New FDA Guidances for November 2018

By Joanne McNelis, Ph.D., RAC (US), Clinical Strategy Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in October are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Self-Monitoring Blood Glucose Test Systems for Over-the-Counter …

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Nov 06

New FDA Guidances for October 2018

By Joanne McNelis, Ph.D., RAC (US), Clinical Strategy Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in October are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Considerations for the Development of Dried Plasma …

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