Category Archive: Drug Development

Apr 24

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 of surrogate biomarkers, nonclinical flexibility, and natural history studies, to assist sponsors in conducting more efficient drug development programs for rare …

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Apr 10

2019 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 Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research – Final Guidance 25 Mar 2019 Rare Diseases: Natural History Studies …

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Mar 12

Lets talk about Patient Engagement

patient engagement , clinical trials

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 meet their recruitment goal, patient engagement plays a key role in the success of a clinical trial. But what is exactly patient engagement and …

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Feb 28

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 approximately 7,000 rare diseases that cumulatively affect more than 25 million Americans, half of which are children.2 In addition, most rare diseases are serious …

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Feb 19

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 diagnosed as having G6PD deficiency. Sally was started on warfarin and there was a problem in achieving the desired therapeutic response.  She was diagnosed as having …

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Feb 11

New 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 meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Rare Diseases: Common Issues in Drug Development Guidance for …

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Jan 29

New 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. Availability of such data has opened the doors for the opportunity to leverage this information when developing drugs, for example in designing clinical trials. Having all this …

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Jan 17

Stay 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 refresh in 2019? I politely suggest your understanding of Reference Safety Information (RSI) in the EU. In Nov 2017, the Clinical Trials Facilitation Group published the Reference …

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Sep 06

New 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 committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Hematologic Malignancy and Oncologic Disease: Considerations for …

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Jan 17

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

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 Medicines Act. These provide for the creation of a new regulatory authority, known as the South African Health Products Regulatory Authority (SAHPRA). This new …

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