Patient-Focused Guidance Writing: FDA Aiming For 'Sweet Spot' In Advice

US FDA’s first guidance on patient data collection methods will be ready by June, and agency wants to get the tone right from the start; agency assures stakeholders it will be “flexible” on accepting new tools.

FDA entrance sign 2016

The US FDA wants to ensure that its promised series of guidances on patient input are drafted with a new target audience in mind: patient advocates who may be new to the regulatory process.

That point was driven home during a Dec. 18 public workshop ahead of the release of the first draft guidance...

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