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New FDA Gudiances for July 2020 and Upcoming Advisory Committee Meetings

August 5, 2020

  By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Pediatric...

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New FDA Gudiances for June 2020 and Upcoming Advisory Committee Meetings

July 5, 2020

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Development...

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

June 13, 2018

By Juliati Rahajeng, Ph.D., Scientist The Food and Drug Administration Reauthorization Act (FDARA) was signed into law by the President...

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

May 16, 2018

By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist The Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs)...

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Submitting IND Safety Reports using us-regional DTD v3.3 versus v2.01: What’s the Difference?

March 27, 2018

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate Submitting IND safety reports to an IND in eCTD format is slightly different...

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Submitting a “Request for Proprietary Name Review” in eCTD format to the FDA

March 1, 2018

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate Per the April 2016 Guidance for Industry entitled, “Contents of a Complete Submission...

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Communicating with the FDA: Important Changes to Formal Meetings with FDA for PDUFA Products

January 22, 2018

By: Robert McNeill, Ph.D., Scientist In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for...

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South Africa is Transitioning to a New Regulator of Medicines and Medical Devices

January 17, 2018

By Nicola Main, Clinical Research Manager and Clinical Trial Operations – Rest of World, South Africa On 01 June 2017,...

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FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies

July 14, 2017

Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist The International Conference on Harmonization (ICH) last updated its guidance “THE...