The goal of this webpage is to connect entrepreneurs with a set of curated links available from the United States Food and Drug Administration (FDA). The webpage contains links to resources that are relevant for early-stage companies developing oncology-related technologies.
The U.S. Food and Drug Administration (FDA) regulates medical devices to assure their safety and effectiveness and develops, and carries out a national program designed to control unnecessary exposures to, and assure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products. The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic (FD&C) Act.
As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The Center is a consumer watchdog in America's healthcare system. CDER's best-known job is to evaluate new drugs before they can be sold. The Center's review of new drug applications not only prevents quackery, but it provides doctors and patients with the information they need to use medicines wisely.
The Center makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.
If you have any questions or suggestions for additional resources, please contact NCI SBIR Development Center Program Director Monique Pond (firstname.lastname@example.org).