Category Archives: Regulatory Submissions

New FDA Guidances for May 2017

By Sheila Plant, Ph.D., R.A.C., Assistant Director, Regulatory Strategy, US at Cato Research One revised draft FDA guidance, released from CBER, and two MAPPs, released from CDER, in May 2017, are posted.  In addition, upcoming advisory committee meetings to be … Continue reading

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New FDA Guidances for March and April 2017

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, and Manual of Policies and Procedures (MAPPs) of interest, released from CDER in March and April are posted. In … Continue reading

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A New Expedited Review Designation: Regenerative Advanced Therapy

By Michelle Villasmil, Ph.D., RAC (U.S.), Regulatory Scientist at Cato Research One of the many changes brought by the 21st Century Cures Act is the new expedited review designation entitled Regenerative Advanced Therapy (with the unfortunate acronym of RAT). FDA … Continue reading

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New FDA Guidances for January 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in January 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more … Continue reading

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What’s New Health Canada? Jan 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy, and Christine Straccini, B.Sc., Regulatory Associate; Cato Research Canada   What’s New in: Therapeutic Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/update-miseajour/index-eng.php Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php Natural and Non-prescription Health … Continue reading

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