The US Food and Drug Administration (FDA) is seeking stakeholder feedback to create a Quantitative Medicine Innovation ...
The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary ...
The World Health Organization (WHO) has published its first interim list of 12 global medical device regulators eligible for ...
By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration ...
Two recent papers published in JAMA have highlighted the potential need for additional regulatory scrutiny for low-risk digital health technologies used by consumers. Gregory Curfman, executive editor ...
Recon: FDA says Replimune's pivotal melanoma study failed to show benefit; FDA guidance on peptides could affect development ...
Based on what was agreed to under the Biosimilar User Fee Amendments (BsUFA III), FDA estimated that its base revenue from the program for FY 2027 needs to bring in $58,926,749 before being adjusted ...
EFPIA has called for lawmakers to go beyond the reductions in clinical trial approval times proposed in the Biotech Act.
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