Blog

New FDA Guidance on Natural History Studies for Rare Diseases

April 24, 2019

In a recent blog post, I summarized a revised FDA guidance issued in January 2019, Rare Diseases: Common Issues in...

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Blog

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...

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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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Blog

Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products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A draft guidance with regards to the formal meetings between the FDA and sponsors or applicants of biosimilar or interchangeable...

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Blog

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

January 24, 2019

As Cervical Health Awareness Month comes to a close, it is a good time to review the state of cervical...

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Blog

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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