Submission of Abbreviated Reports and Synopses in Support of Marketing Applications
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 13, 1999
May 27, 2020
0fb9e1c4-cf27-43e2-b137-274ade81a207
Related Documents
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)
Guidance DocumentOctober 1, 2000Center for Drug Evaluation and Research
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
Guidance DocumentMay 15, 1998Center for Drug Evaluation and Research
E9 Statistical Principles for Clinical Trials
Guidance DocumentSeptember 16, 1998Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox