Lets talk about Patient Engagement
Why does everyone talk about “Patient Engagement” in clinical trials? As trials are becoming longer and more expensive and many...
Revised FDA Guidance on Developing Rare Disease Therapies
Rare diseases, defined as conditions affecting fewer than 200,000 people in the United States, pose a significant health care concern.1...
Pharmacogenetics- Tailoring your product to fit the genes
John received anti-malarial therapy and developed severe hemolytic anemia. He was diagnosed as having G6PD deficiency. Sally was started on...
Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
A draft guidance with regards to the formal meetings between the FDA and sponsors or applicants of biosimilar or interchangeable...
New Year New FDA Strategic Framework on Real World Evidence Program
Overview Today there remains an ever-growing ability to generate, collect, and store vast amounts of health-related data. Availability of such...
Stay on the Safe Side- Reference Safety Information – Europe
Aside from New Year’s resolutions and a clean sweep, what else should you refresh in 2019? I politely suggest your...
Combination immunotherapy: The latest revolution in cancer treatment
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
By Juliati Rahajeng, Ph.D., Scientist The Food and Drug Administration Reauthorization Act (FDARA) was signed into law by the President...
New Meeting Opportunities with FDA through the Model-Informed Drug Development (MIDD) Pilot Program
By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist The Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs)...
Exception from Informed Consent in Emergency Research
by Reshma Jagasia, Ph.D., Scientist by Nicole Tackmann, Ph.D., Clinical Strategy Intern All clinical investigations conducted in the United States...