FDA Guidance Document

FDA Issues Guidance Document on Animal Studies for the Evaluation of Medical Devices

The U.S. Food and Drug Administration (FDA) recently issued General Considerations for Animal Studies Intended to Evaluate Medical Devices – Guidance for Industry and Food and Drug Administration ...

JD Supra

Unpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents

FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking. What do the data show regarding FDA’s ...

MD&M East

2016 FDA Guidance Documents You Should Know

These were the most important guidance documents of the year for medical device manufacturers. Gordon MacFarlane, PhD, RAC and Cynthia Nolte, PhD, RAC This year FDA again issued several guidance ...

Podcast: Rare Disease Day: FDA guidance allowing advancement

Ahead of Rare Disease Day, Abigail Beaney spoke with Robert Barrie and Frankie Fattorini on recent developments in the rare disease space.

Rare disease developers applaud clarity in FDA guidance

Several new guidance documents issued by the FDA are poised to significantly impact the rare disease development landscape.

MobiHealthNews

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...

MD&M East

FDA Issues Guidance Document on Animal Studies for the Evaluation of Medical Devices

Unpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents

2016 FDA Guidance Documents You Should Know

Podcast: Rare Disease Day: FDA guidance allowing advancement

Rare disease developers applaud clarity in FDA guidance

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps

FDA Plans Faster Release of Guidance Documents

FDA Publishes List of Priority Guidance Documents

FDA looks to clarify confirmatory trial mandate for accelerated approvals

FDA Publishes Updated Prior Notice of Imported Food Guidance Document