Real-world data: assessing registries to support regulatory decision-making for drug and biological products : guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Oncology Center of Excellence (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products Data Collection Decision Making Drug Industry Legislation, Drug Government Regulation Pharmaceutical Preparations Registries United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, was intended to accelerate medical product development and bring innovations and advances faster and more efficiently to the patients who need them. Among other provisions, the Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act). In response to the requirements in section 505F, FDA created a framework for a Real-World Evidence (RWE) Program to evaluate the potential use of RWE to help support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help support or satisfy postapproval study requirements. In the context of this program, this guidance provides considerations for sponsors proposing to design a new registry or use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. This guidance does not provide recommendations on choice of study design or statistical methods used to analyze data from registries.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (12 pages))
- NLM Unique ID:
- 9918751183506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918751183506676