Tag Archive: regulatory affairs

Aug 05 2020

New FDA Gudiances for July 2020 and Upcoming Advisory Committee Meetings

  By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans – Final Guidance 31 Jul 2020 Multiple Function Device Products: Policy and Considerations – Final Guidance 29 …

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Jul 05 2020

New FDA Gudiances for June 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry – Final Guidance 30 Jun 2020 Review and Update of Device Establishment Inspection Processes and Standards: Guidance for Industry – Final Guidance 29 Jun 2020 …

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Oct 02 2018

New FDA Guidances for September 2018

By Zachary Swan, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in September are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the …

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Aug 16 2018

New FDA Guidances for June and July 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance …

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Aug 15 2018

What’s New Health Canada?

  By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy   What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html   Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php   Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html   Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html     Health Canada New Guidance Documents (Drugs and Biologics)   Health Canada Guidance Type Date Posted …

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Jul 12 2018

FDA Approval of Epidiolex and the Cannabis-Based Drug Pipeline

By: Kristen Biernat, Cato Research   The Food and Drug Administration (FDA) granted approval of the cannabis-based drug Epidiolex to GW Research Ltd. (GW) on June 25, 2018.1 The FDA’s approval of Epidiolex represents two major milestones for GW: First, it is addresses the unmet need for patients with Lennox-Gastaut syndrome and Dravet syndrome, two …

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Jun 13 2018

2018 Changes in the User Fee Program for Prescription Drugs Under PDUFA VI

By Juliati Rahajeng, Ph.D., Scientist at Cato Research   The Food and Drug Administration Reauthorization Act (FDARA) was signed into law by the President on August 18, 2017. The law comprises the reauthorization of the Prescription Drug User Fee Act (PDUFA), which gives the Food and Drug Administration (FDA) the resources to sustain a predictable …

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Jun 08 2018

New FDA Guidances for May 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Development of a Shared System REMS Guidance for Industry – Draft …

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May 16 2018

New Meeting Opportunities with FDA through the Model-Informed Drug Development (MIDD) Pilot Program

Our Regulatory Experts Can Help!

By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist   The Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2018 to 2022, known as PDUFA VI, includes language to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources, referred to as model-informed drug development …

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May 07 2018

New FDA Guidances for April 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Multiple Function Device Products: Policy and Considerations – Draft Guidance …

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