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...
View ArticleFDA 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 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 ArticleToward Compliance 2.0 : When your Pill is Connected to your Smartphone
By: David Hamel, Fellow Scientist Cato Research Canada The FDA approval of Abilify MyCite (aripiprazole tablets with sensor; by Otsuka) on 13 November 2017 for the treatment of schizophrenia, acute...
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 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 ArticleNew FDA Guidances for August 2018
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 August are posted. In addition, upcoming advisory...
View ArticleStay on the Safe Side- Reference Safety Information – Europe
Vivienne Ben-David, B.Sc. (Pharmacy) PGDip. Project Manager & Associate Director, Pharmacovigilance ROW Cato Research Aside from New Year’s resolutions and a clean sweep, what else should you...
View ArticleNew Year New FDA Strategic Framework on Real World Evidence Program
By Dieanira Erudaitius, Ph.D., Postdoctoral Research Fellow at Cato Research Overview Today there remains an ever-growing ability to generate, collect, and store vast amounts of health-related data....
View ArticleNew FDA Guidances for January 2019
By Zachary Swan, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in January are posted. In addition, upcoming advisory committee...
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Pharmacogenetics- Tailoring your product to fit the genes
Pharmacogenetics – Tailoring your product to fit the genes By Carron Sher, M.D. Senior Clinical Research Physician John received anti-malarial therapy and developed severe hemolytic anemia. He was...
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Revised FDA Guidance on Developing Rare Disease Therapies
by Kristen Biernat, Ph.D., Scientist at Cato Research Rare diseases, defined as conditions affecting fewer than 200,000 people in the United States, pose a significant health care concern.1 There are...
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Lets talk about Patient Engagement
Why does everyone talk about “Patient Engagement” in clinical trials? By Shirley Greenfeld Senior Clinical Research Associate As trials are becoming longer and more expensive and many of them fail to...
View Article2019 March FDA Guidances
Special Interest Guidances/Information Date Posted Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice – Final Guidance 27 Mar 2019...
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New FDA Guidance on Natural History Studies for Rare Diseases
In a recent Ask Cato blog post, I summarized a revised FDA guidance issued in January 2019, Rare Diseases: Common Issues in Drug Development.1 The guidance covers a range of topics, including the use...
View ArticleComplicated Drug Product? FDA Releases New Draft Guidance on Instructions for...
Complicated Drug Product? FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient By Dieanira Erudaitius, Ph.D, Scientist at Cato Research This...
View ArticleNew FDA Guidances for June to August 2019
Special Interest Guidances/Information Date Posted Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian...
View ArticleNew FDA Guidances for September 2019
Special Interest Guidances/Information Date Posted Patient-Focused Drug Development: Methods to Identify What Is Important to Patients – Draft Guidance 30 Sep 2019 Changes to Existing Medical Software...
View ArticleNew FDA Guidances for October 2019 and Upcoming Adcom Meetings
By Sheila Plant, PhD, MHS, RAC (US), Director, Regulatory Strategy at Cato Research Special Interest Guidances/Information Date Posted Assessing User Fees Under the Generic Drug User Fee Amendments of...
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