US FDA outlines broad vision for advancing regulatory science
This article was originally published in SRA
Executive Summary
A new report outlining the US Food and Drug Administration's "broad vision" for advancing regulatory science focuses on seven public health areas that pose the most pressing challenges facing citizens1,2.
You may also be interested in...
Dutch Hospital Resumes Own Manufacture Of Leadiant’s Costly Drug
While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.
Big Win For EMA On Transparency
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.
EU Countries Test Offering Simultaneous Scientific Advice
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: