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USFDA Guidance on Regulatory Considerations for Prescription Drug Use-Related Software
The US Food and Drug Administration (FDA) has issued Regulatory Considerations for Prescription Drug Use-Related Software, a guidance for industry addressing the application of drug labeling requirements to software developed or distributed by, or on behalf of, prescription drug sponsors. The guidance explains how FDA considers software-generated content presented to patients, caregivers, and healthcare professionals, and how this content should be addressed in prescription d
Sharan Murugan
Oct 204 min read
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...
Sharan Murugan
Sep 20, 20232 min read
USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations
The United States Food & Drug Administration released two draft guidelines today (18-May-2023) "Pediatric Drug Development: Regulatory...
Sharan Murugan
May 18, 20232 min read