Clinical Data Summary Pilot Program: FAQsBy druganddevicedigest / 13.07.2022 May 4, 2018 Drug & Device Advisory Group FDA Briefs Clinical Data Summary Pilot Program: FAQs Clinical Data Summary Pilot Program FDA will post study report body, protocol and amendments, and statistical analysis plan for each pivotal study Previous post FAQs on Datasets and patient narratives Redaction of information LEARN Image: FDA Share this: Email Print WhatsApp Like this: Like Loading… Published by Drug & Device Advisory Group View all posts by Drug & Device Advisory Group Leave a Reply Cancel reply Enter your comment here… Fill in your details below or click an icon to log in: Email (required) (Address never made public) Name (required) Website You are commenting using your WordPress.com account. ( Log Out / Change ) You are commenting using your Google account. ( Log Out / Change ) You are commenting using your Twitter account. ( Log Out / Change ) You are commenting using your Facebook account. ( Log Out / Change ) Cancel Connecting to %s Notify me of new comments via email. Notify me of new posts via email. Post navigation 2018 FDA CALENDAR FDA Guidances: Multiple Function Device Products, Pregnant Women in Clinical Trials, Atopic Dermatitis Pediatric Studies, PRO Tool for COPD, BIMO Inspection Information
Clinical Data Summary Pilot Program FDA will post study report body, protocol and amendments, and statistical analysis plan for each pivotal study Previous post FAQs on Datasets and patient narratives Redaction of information LEARN Image: FDA Share this: Email Print WhatsApp Like this: Like Loading… Published by Drug & Device Advisory Group View all posts by Drug & Device Advisory Group
Clinical Data Summary Pilot Program