Fda

(Image: Getty/BrianAJackson)

FDA guidance ‘a step in the right direction’

By Melissa Fassbender

The FDA has published the second in a series of guidance documents that aim to accelerate research and the use of patient input to inform clinical development programs, says Iqvia head.

(Image: Getty/z_wei)

FDA addresses lack of diversity in clinical trials in draft guidance

By Melissa Fassbender

In a bid to increase clinical trial diversity, the FDA published a draft guidance suggesting sponsors rethink exclusion criteria, include children in adult studies when appropriate, use adaptive trials, and make sure other logistical barriers to participation...

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