Food, Drug, and Cosmetic Act amendments to the

When an IVD is developed as a kit or system to be used with specific equipment and is sold to multiple laboratories, it is considered a device in interstate commerce and is subject to premarket review. When the IVD is a novel test, premarket approval (PMA) will be based on the analytical and clinical validation that will determine whether the test is safe and effective for clinical use. When there is evidence that the IVD is substantially equivalent to a legally marketed device, FDA clears such tests under section 510(k) of the Device Amendments to the Food, Drug and Cosmetic Act. The necessary level of evidence and requirements are described in more detail below. 

Delaney amendment Amendment to the Food, Drug, and Cosmetic Act of the Food and Drug Administration of the United States. The amendment states that food additives that cause cancer in humans or animals at any level shall not be considered safe and are, therefore, prohibited. 

The requirement that drugs be both effective and safe did not become law until 1962. The Kefauver-Harris amendment to the Food, Drug, and Cosmetic Act passed in 1962 required the FDA to review all drugs released after 1938 for effectiveness as well as safety. This program established the Drug Efficacy Study Implementation (DESI) and the job was assigned to the National Academy of Sciences—National Research Council, which reviewed the data presented for each drug that had been submitted to the FDA. 

The 1962 Drug Amendment to the Food, Drug and Cosmetic Act (with subsequent amendments)... 

What is the purpose of the 1962 Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act The 1962 Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act required pharmaceutical manufacturers to prove the effectiveness of their medication before the medication could be administered to patients. This act also authorized the Food and Drug Administration to evaluate testing methods used by pharmaceutical manufacturers and required standard labeling of medication. 

Collaboration between academia and the pharmaceutical industry on basic research diminished steadily between 1940 and the 1970s as alternative sources of support for university research (mainly the government) increased and as the growth in industrial research laboratories reduced firms reliance on academia (415). Yet, the amount of clinical research sponsored by the industry and conducted by academia grew significantly over this period, particularly after the 1962 amendments to the Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) required drug sponsors to establish effectiveness as well as safety of new products. 

Copper Chlorophyll. Current efforts to improve the green color of processed foods include the use of copper complexes of chlorophyll derivatives. Copper complexes of pheophytin and pheophorbide are available commercially under the names copper chlorophyll and copper chlorophyllin, respectively. Their use in canned foods, soups, candy, and dairy products is permitted in most European countries under regulatory control of the European Economic Community (47). The Food and Agriculture Organization (FAO) of the United Nations (48) has certified their safe use in foods provided that no more than 200 ppm of free ionizable copper is present. Use of copper-containing chlorophyll derivatives in foods is not allowed in the United States under the Color Additive Amendment to the Food, Drug, and Cosmetic Act of 1938. 

These charges (referring to Amendments to the Food, Drug and Cosmetic Act) are all too familiar to those concerned with the discovery and development of new drugs. This chapter examines the basis of such charges and offers a suggestion regarding research and development. 

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