Category Archive: Regulatory Submissions

Oct 11

New FDA Guidances for September 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory 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 September 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special …

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Sep 25

Time to Approval and the Metrics of Facilitated Regulatory Pathways

By Dr. Jack Snyder, RAC (US, EU, CA, GS), Asst. Managing Director and Clinical Research Physician at Cato Research “Early access pathways” for biomedical product marketing approval have attracted substantial attention recently, as Sarepta Therapeutics’ drug Exondys (eteplirsen) gained accelerated approval based on clinical data from just 12 patients.  In the United States, four “expedited” …

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Aug 14

New FDA Guidances for July 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory 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 July 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest …

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Jul 10

New FDA Guidances for June 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory 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 June 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special …

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Jun 05

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 held in June and July are listed below with links to more information. Special Interest …

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May 08

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 addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest …

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Feb 09

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

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

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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Jan 09

New FDA Guidances for December 2016

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in December 2016 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities …

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