FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies
Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist of Cato Research The International Conference on Harmonization (ICH) last updated its guidance “THE CLINICAL EVALUATION OF QT/QTC...
View ArticleNew 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...
View ArticleNew FDA Guidances for August 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...
View ArticleTime 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...
View ArticleNew 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...
View ArticleWhat’s New Health Canada?
By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate II What’s New in: Therapeutic Products Directorate:...
View ArticleNew FDA Guidances for October and November 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...
View ArticleWhat’s New Health Canada?
By Amelie Rodrigue-Way, PhD, RAC (CAN), Associate Director, Regulatory Strategy What’s New in: Therapeutic Products Directorate:...
View ArticleNew FDA Guidances for December 2017
By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in December 2017 are posted. In addition, upcoming...
View ArticleSouth Africa is Transitioning to a New Regulator of Medicines and Medical...
By Nicola Main, Clinical Research Manager and Clinical Trial Operations – Rest of World Cato Research, South Africa On 01 June 2017, the President of South Africa proclaimed revisions to the...
View ArticleCommunicating with the FDA: Important Changes to Formal Meetings with FDA for...
By: Robert McNeill, Ph.D., Scientist at Cato Research In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for industry titled Formal Meetings between the FDA and...
View ArticleWhat’s New Health Canada?
By Sandra Salem, Ph.D., Regulatory Scientist What’s New in: Therapeutic Products Directorate:...
View ArticleNew FDA Guidances for January 2018
By Sheila Plant, PhD, MHS, RAC (US), Assistant Director, Regulatory Strategy, US, Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in January 2018 are posted. CDRH has...
View ArticleSubmitting a “Request for Proprietary Name Review” in eCTD format to the FDA
By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate at Cato Research Per the April 2016 Guidance for Industry entitled, “Contents of a Complete Submission for the Evaluation of Proprietary...
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Deadline to Begin Submitting Commercial INDs in eCTD Format is May 5, 2018
By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist Beginning on May 5, 2018, all commercial Investigational New Drug Applications (INDs) and master files must be submitted in the electronic...
View ArticleSubmitting IND Safety Reports using us-regional DTD v3.3 versus v2.01: What’s...
By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate at Cato Research Submitting IND safety reports to an IND in eCTD format is slightly different when using us-regional DTD v3.3 versus...
View ArticleNew FDA Guidances for February and March 2018
By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in February and March are posted. In addition, upcoming advisory...
View ArticleNew 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...
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New Meeting Opportunities with FDA through the Model-Informed Drug...
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...
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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...
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