Tag Archives: safety

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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The FDA Wants To Hear Patients’ Voices

The FDA Wants To Hear Patients’ Voices by Joanne McNelis, Ph.D., Scientist at Cato Research In September the FDA announced the creation of its first-ever Patient Engagement Advisory Committee (PEAC) to advise the FDA commissioner on complex issues relating to … Continue reading

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Toxicological/Safety Evaluation of Dietary Supplements Containing Vitamins and Minerals

By Harsh Sancheti, Ph.D., Medical Writer at Cato Research Dietary supplementation of certain vitamins and minerals has resulted in significant positive public health outcomes. Some notable examples include folic acid fortification in wheat or maize flour that has reduced the … 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 May 2013

FDA released 10 guidances in May, including two Q & A guidances, which I always find helpful (Charging for Investigational Drugs Under an IND and Expanded Access to Investigational Drugs for Treatment Use).  Additionally, as directed by FDASIA, a guidance … Continue reading

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