FDA regulates scientific studies
that are designed to develop evidence to
support the safety and effectiveness of
investigational drugs (human and animal),
biological products, and medical devices.
Physicians and other qualified experts
("clinical investigators") who conduct
these studies are required to comply with
applicable statutes and regulations. These
laws and regulations are
intended to ensure the integrity of
clinical data on which product approvals
are based and to help protect the rights,
safety, and welfare of human subjects.
The
following resources are provided to help
investigators, sponsors, and contract
research organizations who conduct clinical studies on investigational new drugs comply with U.S. law and regulations covering good clinical practice (GCP).
General Information
.gif){kind=spacer}
