Cardiovascular and Renal Drugs Advisory Committee
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Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is part of the U.S. Food and Drug Administration (FDA) and advises on matters related to the development, safety, and effectiveness of drugs intended for the treatment of cardiovascular and renal diseases. The committee is based in Silver Spring, Maryland.
Mission
CRDAC's mission is to provide scientific and clinical advice to the FDA regarding drug products for the treatment of cardiovascular and renal conditions. This includes evaluating clinical trial data, discussing drug safety, efficacy, and appropriate labeling, thereby contributing to informed regulatory decisions.[1]
Parent organization
CRDAC is part of the Food and Drug Administration (FDA), which is under the Department of Health and Human Services. The FDA is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
Legislation
While not established by a specific piece of legislation, CRDAC operates under the authority of the FDA, which is empowered by various acts like the Federal Food, Drug, and Cosmetic Act. Its activities are influenced by broader regulatory frameworks concerning drug regulation.
Partners
- Pharmaceutical companies for drug application reviews
- Academic and research institutions for clinical trial data and research
- Other FDA advisory committees for cross-disciplinary advice
Number of employees
The committee does not have permanent employees but consists of appointed members, including experts in cardiology, nephrology, biostatistics, and related fields.
Organization structure
CRDAC's structure includes:
Leader
The committee's proceedings are managed by the Designated Federal Officer (DFO).
Divisions
- No formal divisions; the committee operates as a single entity with members appointed based on their expertise.
List of programs
- Regular meetings to review specific drug applications for cardiovascular and renal treatments
- Discussions on regulatory science related to heart and kidney drug development
- Public meetings to discuss broader issues like drug safety and efficacy in these disease areas[2]
Last total enacted budget
Specific budget information for CRDAC is not publicly disclosed, as it is part of the FDA's broader advisory committee operations.
Staff
Staffing for meetings includes the DFO and support from FDA staff; however, the committee members serve in an advisory capacity.
Funding
Funding for CRDAC activities is part of the FDA's overall budget for advisory committee operations.
Services provided
CRDAC provides recommendations on drug approval, labeling, and post-marketing surveillance for cardiovascular and renal drugs. It focuses on ensuring that these medications are both safe and effective, addressing critical issues like drug interactions, side effects, and long-term outcomes.[3]
Headquarters address
10903 New Hampshire Ave, Silver Spring, MD 20993
History
CRDAC was established to provide scientific and technical advice specific to cardiovascular and renal drugs, with its charter regularly renewed, typically every two years, to reflect the evolving nature of medical science and regulatory needs.
External links
References
- ↑ Food and Drug Administration (2025). "Cardiovascular and Renal Drugs Advisory Committee". FDA.
- ↑ Food and Drug Administration (2025). "Human Drug Advisory Committees". FDA.
- ↑ Food and Drug Administration (2025). "Cardiovascular and Renal Drugs Advisory Committee Meetings". FDA.