Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic
By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to...
Cancer, COVID-19, Continuity
The world is experiencing a major health care crisis. Thus far, over 2.5 million infections with severe acute respiratory syndrome...
Three blockbuster approved cancer drug launches expected in 2020
2019 has been an outstanding year for biotechnology companies developing anti-cancer drugs, as seen from the large number of approvals given by...
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 FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient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 This month, July 2019, the United States Food and Drug Administration (FDA) released a new...
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...
Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?
By Greg Hileman, Ph.D, Senior Director of Regulatory Affairs and Principle Regulatory Scientist On March 5, the FDA approved Spravato...
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...
Revised FDA Guidance on Developing Rare Disease Therapies
by Kristen Biernat, Ph.D., Scientist Rare diseases, defined as conditions affecting fewer than 200,000 people in the United States, pose...
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...
Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
By: Juliati Rahajeng, Ph.D., Clinical Strategy Scientist, and Dieanira Erudaitius, Ph.D., Scientist A draft guidance with regards to the formal...