Food and Drug Administration Revitalization Act

Great Seal of the United States (obverse)

Food and Drug Administration Revitalization Act

The Food and Drug Administration Revitalization Act (FDARA) is a significant piece of legislation in the United States that aims to enhance the capabilities and resources of the Food and Drug Administration (FDA). The act focuses on improving the efficiency, effectiveness, and transparency of the FDA in its mission to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

Background

The FDA is a federal agency of the United States Department of Health and Human Services (HHS). It is responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics, and blood products. Over the years, the FDA has faced numerous challenges, including limited resources, increasing workloads, and the need for modernization. The FDARA was introduced to address these issues and to revitalize the agency's operations.

Key Provisions

The FDARA includes several key provisions aimed at strengthening the FDA:

• User Fees: The act authorizes the collection of user fees from the pharmaceutical and medical device industries. These fees are used to fund the review and approval processes for new drugs and devices, thereby reducing the time it takes for products to reach the market.
• Post-Market Surveillance: The act enhances the FDA's ability to monitor the safety of products after they have been approved and are on the market. This includes improved adverse event reporting systems and increased authority to require post-market studies.
• Regulatory Science Initiatives: The act supports the development of new scientific tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.
• Transparency and Accountability: The act mandates greater transparency in the FDA's decision-making processes and requires regular reporting to Congress on the agency's performance and use of resources.
• Innovation and Access: The act encourages the development of innovative medical products and facilitates faster access to these products for patients in need.

Impact

The FDARA has had a significant impact on the FDA's operations. By providing additional resources and authority, the act has enabled the FDA to improve its review processes, enhance post-market surveillance, and foster innovation in the development of new medical products. The increased transparency and accountability measures have also helped to build public trust in the FDA's regulatory activities.

Related Legislation

The FDARA is part of a broader legislative framework aimed at improving public health and safety. Related legislation includes the Food and Drug Administration Modernization Act, the Prescription Drug User Fee Act, and the 21st Century Cures Act.

See Also

• Food and Drug Administration
• United States Department of Health and Human Services
• Prescription Drug User Fee Act
• Food and Drug Administration Modernization Act
• 21st Century Cures Act

External Links

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