Tag Archives: IND

Jump on the Development Safety Update Report (DSUR) Bandwagon!

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Cato Research Canada. If you have an open Investigational New Drug application (IND) then you are all too familiar with the periodic reporting requirements. Many US-based sponsors have opted for the Annual … Continue reading

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New FDA Guidances for July 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in July 2015, are posted.  In addition, upcoming advisory committee meetings to be held in September are also listed below … Continue reading

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New FDA Guidances for May 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in May, are posted. In addition, upcoming advisory committee meetings and other public meetings hosted by FDA are listed … Continue reading

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New FDA Guidances for April 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in April 2015, are posted.  In addition, upcoming advisory committee meetings to be held in the next couple … Continue reading

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New FDA Guidances for March 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in March 2015, are posted.  Two updates to the CDER Manual of Policies and Procedures (MAPP) are included.  … Continue reading

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