Category Archive: Medical Research

Mar 23 2017

CANCER IMMUNOTHERAPY: A NEW HOPE

By Reshma Jagasia, Ph.D, Scientist at Cato Research The current standard of care for cancer treatment is surgery, chemotherapy, and radiation therapy – a standard that has persisted for decades. These treatments are invasive and not specific, killing healthy cells and tissues along with tumors. In the past decade, more targeted therapies have emerged, including …

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Mar 06 2017

New FDA Guidances for February 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 February 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Q11 Development and Manufacture of Drug Substances—Questions and Answers …

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Feb 09 2017

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 provides brief guidance for a RAT designation on their website (provided below). A drug is …

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Feb 03 2017

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 information. Special Interest Guidances/Information Date Posted Drug and Device Manufacturer Communications With Payors, Formulary Committees, …

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Jan 18 2017

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 Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php     Health Canada New Guidance Documents (Drugs and Biologics): October – …

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Dec 02 2016

New FDA Guidances for October and November 2016

By Michelle Villasmil, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in October and November 2016 are posted. In addition, upcoming advisory committee meetings to be held in the next month are listed below with links to more information.   Special Interest Guidances/Information Date Posted Mitigating …

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Oct 26 2016

NORD Summit 2016 Highlights

By Kimberley Cummings, Ph.D., RAC (US), Vice President, Scientific & Regulatory Strategy and Operations Cato Research   The National Organization for Rare Disorders (NORD) held their annual Rare Diseases and Orphan Products Breakthrough Summit in Arlington, VA on October 17th and 18th.  If you have never been to this meeting before, it is the most …

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Oct 20 2016

Precision Medicine and the FDA

by Reshma Jagasia, Ph.D., Scientist at Cato Research “Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood transfusion to a blood type — that was an important discovery. What if matching a cancer cure to our …

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Oct 12 2016

New FDA Guidances for September 2016

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 September 2016, are posted. In addition, upcoming advisory committee meetings to be held in the next month are listed below with links to more information.   Special Interest Guidances/Information Date Posted Q7 …

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Sep 12 2016

New FDA Guidances for August 2016

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 August 2016, are posted. One recent CDER Manual of Policies and Procedures (MAPP) regarding a change in hard gelatin capsule shell suppliers is included.  In addition, upcoming advisory committee meetings to be …

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