Blog

Revised FDA Guidance on Developing Rare Disease Therapies

février 28, 2019

by Kristen Biernat, Ph.D., Scientist Rare diseases, defined as conditions affecting fewer than 200,000 people in the United States, pose...

Blog

Pharmacogenetics- Tailoring your product to fit the genes

février 19, 2019

Pharmacogenetics – Tailoring your product to fit the genes By Carron Sher, M.D. Senior Clinical Research Physician   John received...

Blog

Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

février 15, 2019

By: Juliati Rahajeng, Ph.D., Clinical Strategy Scientist, and Dieanira Erudaitius, Ph.D., Scientist A draft guidance with regards to the formal...

Blog

New Year New FDA Strategic Framework on Real World Evidence Program

janvier 29, 2019

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

Blog

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

janvier 24, 2019

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

Blog

Stay on the Safe Side- Reference Safety Information – Europe

janvier 17, 2019

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

Blog

Combination immunotherapy: The latest revolution in cancer treatment

septembre 13, 2018

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

Blog

2018 Changes in the User Fee Program for Prescription Drugs Under PDUFA VI

juin 13, 2018

By Juliati Rahajeng, Ph.D., Scientist The Food and Drug Administration Reauthorization Act (FDARA) was signed into law by the President...

Blog

New Meeting Opportunities with FDA through the Model-Informed Drug Development (MIDD) Pilot Program

mai 16, 2018

By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist The Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs)...

Blog

Exception from Informed Consent in Emergency Research

avril 25, 2018

by Reshma Jagasia, Ph.D., Scientist by Nicole Tackmann, Ph.D., Clinical Strategy Intern All clinical investigations conducted in the United States...