Food and Drug Administration
  • Yale University

    Yale School of Medicine (YSM) and its Yale Center for Clinical Investigation (YCCI) has had great success addressing the issue of minority participation in clinical trials. Two elements that are key to the successes at Yale are electronic health record strategies and community engagement, through the Cultural Ambassador program (partnership between Yale, the African Methodist Episcopal Zion Church

  • Case Western Reserve University

    The CWRU School of Medicine is proud to sponsor a new non-credit course entitled "FDA Regulation in Entrepreneurship and Clinical Research Management". The goal of this course is to provide foundational knowledge in and understanding of moving your technology through the FDA approval process. The course will include a series of instructors, including both local experts as well as nationally

  • The University of Rochester's eighth annual America’s Got Regulatory Science Talent student competition, hosted by the University of Rochester Clinical and Translational Science Institute, drew the largest number of competing teams in its history. On March 4, 2021, twelve teams faced off for a chance at first prize: to present their novel regulatory science ideas to a panel of scientists from the

  • NCATS has provided the FDA with access to the N3C Data Enclave. FDA investigators interested in accessing N3C COVID-19 data must complete appropriate human subjects and NIH security training, review and abide by NCATS technology transfer requirements, and submit a Data Use Request (DUR) detailing their proposed project and use of N3C data. For details on how FDA investigators can access the N3C

  • The Center for Leading Innovation & Collaboration (CLIC) hosted three sessions of interactive conversations with leaders who shared their knowledge about career opportunities in industry, government, and scientific societies. These sessions explore careers in Industry, Government, and at the NIH.
  • University Of Rochester

    The goal of the core training modules is to cultivate advanced understanding of research topics. Each of the ten learning modules covers a different topic area.

  • Duke University

    This training provides information regarding the sponsor and investigator requirements for an IND or IDE as well as resources to ensure compliance with FDA regulations. There are two separate training modules that each focus on the requirements for the specific regulatory application that the sponsor or sponsor-investigator holds. Sponsors who hold an IND (for drugs and biologics) can complete the

  • The Center for Leading Innovation & Collaboration (CLIC) hosted three sessions of interactive conversations with leaders who shared their knowledge about career opportunities in industry, government, and scientific societies. This session explores careers in government. Facilitator Rebecca Brown, MEd, MN, RN, PHN | Clinical and Translational Science Institute TL1 Scholar University of Minnesota -

  • The Translational Science Interagency Fellowship (TSIF) is a new postdoctoral fellowship opportunity developed by the National Center for Advancing Translational Sciences (NCATS) and the U.S. Food and Drug Administration (FDA). Fellows will be jointly mentored by NCATS and FDA scientists on a research project of mutual interest to both organizations. Fellows in this program will develop skills of

  • NIH-Logo
    National Institutes of Health
    The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) and the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) are co-hosting a virtual Workshop on Systemic Immunogenicity Considerations for Adeno-Associated Virus (AAV)-Mediated Gene Therapy. This meeting will bring together scientists
  • A new study at Washington University School of Medicine in St. Louis will investigate whether two different antimalarial drugs, including hydroxychloroquine, alone or in combination with a common antibiotic, is effective in treating patients with COVID-19. The drugs to be used in the trial were donated by Cigna/Express Scripts, and the trial will include patients hospitalized with COVID-19 at

  • University Of Rochester
    Georgetown University
    Competencies for regulatory science, which is a growing discipline in medical-related applications. Competencies for this complex field were identified and categorized into 11 Thematic Areas. These areas are based on a subset of the FDA’s priority areas and are accompanied by explanations of their development and broader recommendations to enrich education and training. View Full Publication
  • CD2H-teal
    Center for Data to Health

    The COVID-19 global emergency raises many difficult questions, such as: What are the key risk factors, what are the best prognostic indicators, what are best practices for ethical resource allocation, and which drugs are the most viable candidates for patients? To address these and many other questions, the National Center for Data to Health (CD2H) and NCATS are leading the creation of a

  • *Applications will be reviewed on a rolling-basis. A research opportunity is available in the Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. Under the Prescription Drug User Fee Act (PDUFA), the CDER Rare Diseases Program (RDP) is tasked with several commitments regarding rare disease clinical development programs

  • University Of North Carolina Chapel Hill
    Duke University
    Wake Forest University Health Sciences
    Medical University Of South Carolina
    University Of Miami School Of Medicine
    Virginia Commonwealth University
    ReGARDD provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics and medical devices. Investigational New Drug or Biologic Investigational Device Exemption Educational Videos ReGARDD Sponsored Events Who We Are The Regulatory Guidance for Academic Research of Drugs and
  • As a result of clinical trials conducted in the CCTSI’s pediatric Clinical and Translational Research Center (CTRC) at Children’s Colorado, ther US FDA has approved new breakthrough therapy for cystic fibrosis (CF), a genetic disease that leads to lung, digestive, endocrine and nutritional problems. Researchers from Children’s Hospital Colorado were part of a national network that oversaw clinical

  • Arun Sanyal, a professor of Medicine and co-director of the Wright Center for Clinical & Translational Research's education core, has helped establish the scientific foundation for what may soon become the first approved drug therapy for NASH, a severe form of fatty liver disease closely related to obesity and Type 2 diabetes. Patients with nonalcoholic steatohepatitis (NASH), a chronic liver

  • Repurposing Off-Patent Drugs
    Repurposing Off-Patent Drugs: Research & Regulatory Challenges workshop is hosted by NCATS Cures Acceleration Network Review Board & FDA Office of Medical Policy & Center for Drug Evaluation and Research(CDER) and Reagan‐Udall Foundation and will explore obstacles to finding new uses for drugs that are already on the market but lack commercial and regulatory incentives for research and development
  • University Of Pennsylvania
    Academic Entrepreneurship for Medical and Health Scientists, is a free open education resource that can be used asynchronously in courses, workshops, pilot grant programs, and by individuals. Who is an academic entrepreneur? Faculty, staff, or students turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and the public and seeking