Glossary

Food, Drug, and Cosmetic Act

Food, Drug and Cosmetic Act (United States)

Food and Drug Administration; an agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services.

A list of commitments and requirements by the FDA for each investigator performing drug/biologic studies. Also referred to as a statement of the investigator.

The official form of notification prepared at the conclusion of an inspection (without review by FDA management) listing observations of perceived violations of Good Manufacturing Practices that may constitute violations of law in the opinion of an inspector. Originally intended to inform companies of possible product adulteration, they must be replied to satisfactorily and/or corrective action taken in order to alleviate any offensive notification and avoid action from the FDA (i.e., plant shut-down). Accessible through the Freedom of Information Act to competitors, potential customers, and the media, 483s can lead to withholding of product approvals, may come into play in due diligence phases of acquisitions and mergers, and can potentially cost companies money.

The 1997 Modernization Act moved in the direction of “reform”; thus, most of its requirements were in the direction of reducing FDA bureaucracy and speeding drugs and devices to patients. The act was, however, at best a modest reform package. Specifically, the Modernization Act reauthorized user fees for another five years, codified rules for fast-track approval, codified the rule that only one adequate and well-controlled clinical study and confirmatory evidence could be the basis of approval, and codified restrictive FDA policies on dissemination of information regarding off-label uses of drugs. (Washington Legal Foundation v. Friedman found such restrictions unconstitutional and further opened up the ability of firms to disseminate off-label information). Concerning medical devices, the Modernization Act exempted most Class I and some Class II devices from premarket approval, and it increased physician authority to use investigational devices. Finally, in a variety of clauses, the FDA was required to provide manufacturers with better and more timely information concerning its procedures. More information is available in the history section. The bill can be found online here.

Food and Drug Administration Ammendments Act

Food and Drug Administration Modernization Act

Floppy Disk Drive

Final Draft International Standard (ISO document stage)

Food and Drug Law Institute

Functional Design Specification

Analysis of the known or anticipated need for a product, system, or component to assess the degree to which the requirements, designs, or plans can be implemented.

The most common operating mode for rDNA fermentation. After an initial partial charge of media to the fermentor and seed transfer, sterile media is added at measured rates during the balance of the fermentation cycle. Cell mass and broth are withdrawn only at the end of the cycle.

Standards published by U.S. Department of Commerce, National Institute of Standards and Technology, formerly National Bureau of Standards. These standards are intended to be binding only upon federal agencies.

Another short reference, along with the phrase “Common Rule” for the Federal Policy for the Protection of Human Subjects in Research (56 FR 28003).

The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Currently, sixteen federal agencies have adopted the Federal Policy.

The government’s publication in which final and proposed rules or notices are published.

The document that use to establish standard classes of air cleanliness for airborne particulate levels in cleanrooms and clean zones. It prescribed methods for classes of air cleanliness for airborne particulate levels in cleanrooms and clean zones. It prescribed methods for class verification and monitoring of air cleanliness. It also addressed certain other factors but only as they affected control of airborne particulate contamination. Federal Standard 209E has been replaced by ISO 14644-1/2.

Set up in 1915 to restrain monopoly, the FTC monitored drug advertising from its inception until 1962, when the regulation of advertising of prescription drugs matter was transferred to the FDA. The FTC still regulates the advertising of over-the-counter drugs, with a few exceptions, notably aspirin. On food products, the FDA and the FTC have split responsibilities, with the FDA regulating food labeling and the FTC regulating food advertising.