Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?

March 22, 2019

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

March 12, 2019

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

February 28, 2019

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

February 19, 2019

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Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

February 15, 2019

By: Juliati Rahajeng, Ph.D., Clinical Strategy Scientist, and Dieanira Erudaitius, Ph.D., Scientist A draft guidance with regards to the formal...


New Year New FDA Strategic Framework on Real World Evidence Program

January 29, 2019

By Dieanira Erudaitius, Ph.D., Postdoctoral Research Fellow Overview Today there remains an ever-growing ability to generate, collect, and store vast...


Cervical Health Awareness Month – Cervical Cancer: Prevention, Detection, Development

January 24, 2019

By Amy Lane, Scientist As Cervical Health Awareness Month comes to a close, it is a good time to review...


Stay on the Safe Side- Reference Safety Information – Europe

January 17, 2019

Vivienne Ben-David, B.Sc. (Pharmacy) PGDip. Project Manager & Associate Director, Pharmacovigilance ROW Aside from New Year’s resolutions and a clean...


Combination immunotherapy: The latest revolution in cancer treatment

September 13, 2018

An analysis of the clinical landscape The present focus in the treatment of cancer is immunotherapy, in particular immunotherapies that...


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...