PubMed Health⌕ Search

PubMed · 7185099

A successful peer review program for regulatory decisions.

Abstract

A unique peer review program for Federal agencies has been operating since 1962 to provide opinions of leading investigators for sponsors in various fields of the life sciences. The most notable study has recently been completed for the U.S. Food and Drug Administration on the Generally Recognized as Safe (GRAS) food ingredients. Over 400 substances were evaluated by a Select Committee over a 10-year period and evaluative reports were submitted to the regulatory agency. Based in part on these reports made available for public comments, the FDA has been able to develop decisions for appropriate actions on the health aspects of these food ingredients. A comprehensive report on the work of the Select Committee on GRAS substances will be published in the archival literature.

Explore related subjects

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

K D Fisher. 1982. A successful peer review program for regulatory decisions.. https://doi.org/10.1016/0273-2300(82)90006-x

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

Risk assessment and the credibility of federal regulatory policy: an FDA perspective.

FDA's fundamental goals are to protect and promote the public health, using the best possible science and the law. The evolution of food safety policy toward potential carcinogens reflects a conscious decision by the agency and Administration to use risk assessment in carrying out these goals. Examples include FDA policies toward assessing the safety of animal drug residues, setting specifications for constituents of food and color additives, and most recently, a common sense de minimis interpretation of the "Delaney clause." While committed to risk assessment as a useful tool, FDA acknowledges that judgments must be made on less than perfect data. In addition, recent history shows that there may be a serious "credibility gap" in public acceptance of regulatory toxicology. To ensure that there is an adequate science base for regulatory decisions, the challenge is twofold: First, the data necessary for sound safety evaluations in individual cases must be developed, based on current knowledge; and, second, the validity of assumptions underlying risk assessment should be tested and refined and scientific consensus achieved. Otherwise, risk management policy will rely on assessments based on extremely conservative assumptions, tending to overestimate risk. Risk assessment assumptions must also be better communicated to policymakers and the public. If these challenges are successfully addressed, public confidence in marketed products, and in science-based regulatory policy, will be enhanced.

Legislation, Food↗