Blog

Lets talk about Patient Engagement

March 12, 2019

Why does everyone talk about “Patient Engagement” in clinical trials? As trials are becoming longer and more expensive and many...

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Blog

Revised FDA Guidance on Developing Rare Disease Therapies

February 28, 2019

Rare diseases, defined as conditions affecting fewer than 200,000 people in the United States, pose a significant health care concern.1...

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Blog

Pharmacogenetics- Tailoring your product to fit the genes

February 19, 2019

John received anti-malarial therapy and developed severe hemolytic anemia.  He was diagnosed as having G6PD deficiency. Sally was started on...

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Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

February 15, 2019

A draft guidance with regards to the formal meetings between the FDA and sponsors or applicants of biosimilar or interchangeable...

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New Year New FDA Strategic Framework on Real World Evidence Program

January 29, 2019

Overview Today there remains an ever-growing ability to generate, collect, and store vast amounts of health-related data. Availability of such...

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Stay on the Safe Side- Reference Safety Information – Europe

January 17, 2019

Aside from New Year’s resolutions and a clean sweep, what else should you refresh in 2019? I politely suggest your...

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Blog

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...

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Blog

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...

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

May 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)...

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Blog

Exception from Informed Consent in Emergency Research

April 25, 2018

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

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