- 21st Century Review Initiative
- Computational Science Center
- Critical Path Initiative
- Equal Voice Initiative
- Modernizing FDA's New Drugs Regulatory Program
- Pharmaceutical Quality for the 21st Century
- Rare Disease Cures Accelerator
- Safety First Initiative
- Safe Use Initiative
- Scientific Public Private Partnerships and Consortia
- Sentinel Initiative
- Transparency Initiative
- Unapproved Drugs Initiative
21st Century Review Initiative
The 21st Century Review Initiative is a set of performance standards the Center for Drug Evaluation and Research (CDER) follows when doing drug reviews that involve multiple offices. The standards address meetings and timelines to identify problems early in the review process. The goal is to make the drug review process more organized and integrated, and ensure all decision makers are heard. Review team members are mutually accountable for raising and addressing differing points in a timely manner over the course of the drug review.
Computational Science Center
The Computational Science Center (CSC) will provide high-quality quantitative analysis of information on product safety, effectiveness, and quality. The development of this core infrastructure for CDER’s scientific community will help support a number of ongoing efforts in pre-market development, modernization of drug review, post-market safety, and drug quality. The benefits to CDER reviewers will include more time to complete reviews and more transparency in decision making and documentation. Key CSC projects include developing data standards and expanding the use of electronic review tools.
Critical Path Initiative
The Critical Path Initiative is the Food and Drug Administration's (FDA) effort to stimulate and assist a national effort to modernize the scientific process—the Critical Path—through which FDA-regulated products are developed, evaluated, and manufactured. The Critical Path needs to be improved so that medical discoveries can move from the laboratory to consumers more efficiently. FDA has called for a joint effort of industry, academic researchers, government agencies, professional societies, trade associations, patient advocacy groups, and others to help.
More information about FDA's Critical Path Initiative
Equal Voice Initiative
The Equal Voice Initiative applies to the review of all product applications. It’s an operational philosophy and set of practices to ensure that each professional viewpoint has been fully expressed, understood, and brought into the decision-making process. When there is disagreement among a review team, each discipline must voice its concerns. This process engages the entire team in scientific debate and brings each viewpoint into discussion so that a decision can be made at the team level. It doesn’t mean that everyone necessarily agrees with the decision, but it ensures that all scientific and regulatory experts have input before a decision is made.
In 2017, FDA’s Center for Drug Evaluation and Research (CDER) embarked on an initiative to modernize the New Drugs Regulatory Program. This effort will allow CDER to better serve patients and better support staff in their work to carry out the center’s mission – to protect and promote health by making sure that human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients. We are working to build on our past successes and strengths by implementing problem-focused, interdisciplinary, team-based approaches so we can meet the challenges of evolving science, new drug platforms, and new drug targets, while incorporating the patient voice in development.
More information about Modernizing FDA's New Drugs Regulatory Program
Pharmaceutical Quality for the 21st Century
FDA continues to make progress with Pharmaceutical Quality for the 21st Century. Introduced by FDA in 2002, this initiative modernizes FDA's regulation of pharmaceutical quality for veterinary and human drugs, and select human biological products such as vaccines. The initiative includes issues related to product quality, with current good manufacturing practices being an important tool for improving overall product quality. Several parts of FDA have been actively involved in improving the regulation of pharmaceuticals in the 21st Century.
More information about Pharmaceutical Quality for the 21st Century
Rare Disease Cures Accelerator
Through the Rare Disease Cures Accelerator, FDA is looking to facilitate a cooperative approach and common standardized platforms to better characterize rare diseases, incorporate the patient’s perspective in clinical outcome assessment measures, and build clinical trial readiness in the pre-competitive space.
More information about CDER's Rare Disease Cures Accelerator
Safety First Initiative
The Safety First Initiative ensures drug safety throughout the drug lifecycle by giving pre-marketing drug review and post-marketing safety equal focus. This calls for inter-office, multidisciplinary safety-issue teams to assess significant safety issues, recommend actions, and monitor sponsors’ activities.
Safe Use Initiative
The Safe Use Initiative is designed to combat medication misuse and errors. Many problems with the medicines people take are caused by preventable errors. This includes people taking medicines inappropriately, or receiving the wrong medicine or the wrong dose from their doctors or pharmacies. As part of this long-term initiative, CDER is bringing together various parts of the health care system to develop interventions that measurably reduce preventable harm from medications.
More information about FDA's Safe Use Initiative
Scientific Public Private Partnerships and Consortia
Scientific Public Private Partnerships and Consortia encourages collaborations with other government agencies, global organizations, academia, industry, patient advocacy groups, and other stakeholders, to promote the development of new tools, methods and approaches to foster innovation and bring efficiency into the FDA regulated product development.
More information about FDA's Scientific Public Private Partnerships and Consortia
The goal of the Sentinel Initiative is to create a national, integrated electronic system (the Sentinel System) for monitoring medical product safety. Monitoring the safety of its regulated products is a major part of FDA’s mission to protect public health. The Sentinel System would enable FDA to actively query diverse automated healthcare data holders—like electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely.
More information about FDA's Sentinel Initiative
CDER participates in the FDA's Transparency Task Force. This task force recommends ways to make information about FDA activities and decision making more readily available to the public. The Transparency Initiative is consistent with memoranda that President Obama issued in January 2009, expressing a commitment to promote openness in government.
More information about FDA's Transparency Initiative
Unapproved Drugs Initiative
An FDA guidance, "Marketed Unapproved Drugs - Compliance Policy Guide," makes clear that firms illegally marketing drugs without FDA approval need to submit applications showing that their products are safe and effective before continuing to market those products. FDA's actions against unapproved drugs are part of the agency's broader initiative, which ensures that consumers and the health care community are provided with established and emerging drug safety information so that they can make the best possible medical decisions about the safe and effective use of drugs.
More information about unapproved drugs