Pharmaceutical Industry News Roundup: August 2019

by Staff Writer

Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection of top stories to keep an eye on:

Former FDA commissioners seek to expand use of RWE in regulatory payment decisions—Regulatory Focus

Shortly after the US Food and Drug Administration (FDA) published its “Framework for FDA’s Real-World Evidence Program,” the Bipartisan Policy Center created recommendations in using real-world evidence in regulatory and payment decision-making. As the report notes, there are significant areas for improvement in this emerging area in the drug development space.

Michael Mezher has the full story here

Industry seeks more detail from FDA guidance on trial diversity CenterWatch

Shortly after releasing its guidance on broadening eligibility for clinical trial participants to increase diversity, many in the industry seek clarifications. Several commenters on the guidance asked the FDA for a statistical model to help them.

Read the full article by Colin Stoecker

FDA, ICH seek comments on “Quality by Design” draft guidelineCenterWatch

Stakeholders have until September 30, 2019 to provide comments on the revision of ICH E8. This revision is part of the International Council on Harmonisation’s (ICH) efforts to update trial standards.

Access the full story by Leslie Ramsey and James Miessler here

Guidance on substantial amendments to a clinical trial in the UK leaves the EU with no deal—gov.uk

This recently-updated guidance covers important changes to clinical trials in the UK. Specifically, the guidance highlights changes in the trial sponsor/legal representative, investigational medicinal product certification and importation, and amendments to the Research Ethics Committee.  

View the entire guidance here

Webinar alert: MichBio U presents “The Programmers’ Approach to Real World Data and Using Real World Evidence in Research and Healthcare” —MichBio

This webinar will help guide individuals towards a better understanding of core concepts and requirements for using real-world data (RWD). Be sure to save your spot, as the webinar will delve into how to use real-world evidence (RWE) in drug development from the perspective of a clinical trial programmer and data analyst. 

Register for this webinar today to save your spot!

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