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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 www.hhs.gov/ohrp/belmontArchive.html)
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
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 gcp.questions@fda.hhs.gov 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)
From Test Tube to
Patient: Improving Health Through Human Drugs
This FDA publication 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.
"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 The 2009 edition of the International Compilation of Human Subject Protections has just been released and is now available on-line. The document can be seen at: http://www.hhs.gov/ohrp/international/HSPCompilation.pdf.
Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world.
The President's Council on Bioethics
This council advises the President of the United States on ethical issues related
to 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.
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