Complicated Drug Product? FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient
This month, July 2019, the United States Food and Drug Administration (FDA) released a new draft guidance to meet Prescription...
New FDA Guidance on Natural History Studies for Rare Diseases
In a recent blog post, I summarized a revised FDA guidance issued in January 2019, Rare Diseases: Common Issues in...
Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?
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
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Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
A draft guidance with regards to the formal meetings between the FDA and sponsors or applicants of biosimilar or interchangeable...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...