- Belmont Report
Based on the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978), the Department of Health and Human Services (HHS) revised and expanded its regulations for the protection of human subjects, 45 CFR part 46, in the late 1970s and early 1980s. In 1978, the Commission’s report "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" was published. It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report. (Extracted from information posted on the DHHS OHRP web site on the Belmont Report; see http://www.hhs.gov/ohrp/archive/belmontArchive.html#histReport)
- Comparison of FDA and HHS Regulations
A chart comparing FDA's regulations for human subject protection with those of the Department of Health and Human Services.
- Determination of Mode of Action in Combination Products (PDF - 13KB)
This rule defines "mode of action" and "primary mode of action" and sets forth the algorithm FDA will use to assign combination products to an agency component for regulatory oversight.
- E-Mail Messages
Copies of e-mail messages (including the original inquiry and associated reply(ies)) that have been submitted by the public to the Good Clinical Practice Program’s firstname.lastname@example.org e-mail account. These e-mail messages have been redacted to the extent permitted by the Freedom of Information Act.
- "FDA Issues Advice to Make Earliest Stages Of Clinical Drug Development More Efficient"
FDA Press Release (Jan. 12, 2006)
- Improving Health Through Human Drugs
This FDA publication, originally titled From Test Tube to Patient: Improving Health Through Human Drugs, tells the story of new drug development in the United States. Articles discuss various aspects of drug development--from test tube to medicine cabinet. This is an excellent primer for learning about the drug development and approval process.
- FDA and Clinical Drug Trials: A Short History
- GCP Training Information
- "Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products"
FDA issued this major report identifying both the problems and potential solutions to the daunting task of ensuring that the unprecedented breakthroughs in medical science are demonstrated to be safe and effective for patients as quickly and inexpensively as possible. Titled "Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products," the report carefully examines the "Critical Path" of medical product development -- the crucial steps that determine whether and how quickly a medical discovery becomes a reliable medical treatment for patients.
- International Compilation of Human Subject Protections (PDF - 877KB)
OHRP/DHHS maintains and updates yearly the International Compilation of Human Subject Protections. The most current version of the document is accessible at the link above.
- The President's Council on Bioethics
This council advises the President of the United States on ethical issues relatedto advances in biomedical science and technology. This web site contains many useful references on ethical issues that arise from advances in biotechnology and biomedical sciences.