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Research and Development › Labeling › Food and Drug Administration (FDA)

Hogan Lovells

FDA announces public meeting on pediatric exclusivity and drug development

Hogan Lovells on

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act”...more

J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

J.S. Held on

Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

Wilson Sonsini Goodrich & Rosati

FDA Outlines Considerations for the Development and Labeling of Companion Diagnostics for Use with a Specific Group or Class of...

Wilson Sonsini Goodrich & Rosati on

Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more

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