Science & Research
Science and Research Special Topics
This section provides activities dealing with on-going topics that are prominent to the Public, topics that don't easily fit into other categories, or topics that the the Public do not realize FDA is involved in.
Women's Health Research
The Office of Women's Health (OWH) Science Program plays an integral role in promoting the scientific understanding of sex and gender differences in disease burden, treatment and response. OWH advocates for the study of sex differences in clinical research including clinical trials for FDA regulated products through adequate inclusion of women and sex based analysis. OWH accomplishes these goals through partnerships and collaborations with scientists within and outside the FDA.
Pediatrics
The Office of Pediatric Therapeutics Science and Research Activities include work with our international colleagues, academia, NIH, WHO and professional and advocacy organizations. Efforts are directed towards analysis of submitted pediatric trials, identified ethical and safety issues, and publication and dissemination of data and results.
Critical Path Initiative
The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or "proof of concept" into a medical product.
Nanotechnology
The US Food and Drug Administration regulates a wide range of products, including foods, cosmetics, drugs, devices, and veterinary products, some of which may utilize nanotechnology or contain nanomaterials. The FDA has not established its own formal definition, though the agency participated in the development of the NNI definition of "nanotechnology." Using that definition, nanotechnology relevant to the FDA might include research and technology development that both satisfies the NNI definition and relates to a product regulated by FDA.
Running Clinical Trials
The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA. In relation to Good Clinical Practice, the Good Clinical Practice Program:
- Coordinates FDA policies
- Contributes to leadership and direction through participation in FDA's Human Subject Protection/Bioresearch Monitoring Council
- Coordinates FDA's Bioresearch Monitoring program with respect to clinical trials, working together with FDA's Office of Regulatory Affairs (ORA)
- Contributes to international Good Clinical Practice harmonization activities
- Plans and conducts training and outreach programs
- Serves as a liaison with the HHS Office for Human Research Protection (OHRP) and other federal agencies and external stakeholders committed to the protection of human research participants
Peer Review of Scientific Information and Assessments
The agenda describes all the planned agency peer reviews for influential scientific information and highly influential scientific assessments that are subject to the OMB Bulletin. The agenda contains key information as it becomes available including the preliminary title, subject and purpose of the planned report; the FDA operating division and office conducting the review and the name of the agency contact person; the peer review schedule; the use of a letter review, panel review or other mechanism; and the opportunities for public comment, if any are planned.
Peer Review of Scientific Information and Assessments
Pandemic and Avian Influenza
Pandemic influenza (flu) is a significant global public health threat. Preparedness has been recognized as a critical local, national and worldwide priority. The Center for Biologics Evaluation and Research (CBER) plays a significant role in fostering development and evaluation, as well as facilitating availability and access to safe and effective biological products that protect and promote public health. As a designated World Health Organization (WHO) Essential Regulatory Laboratory (ERL), CBER influenza laboratory derives and provides reference strains to manufacturers for both seasonal and pandemic flu. In collaboration with CBER’s WHO ERL, CBER Division of Product Quality develops key reagents used by manufacturers to assess influenza vaccine potency for lot release.
Pandemic and Avian Influenza Site