Food and Drug Administration Modernization Act

Before the Food and Drug Administration Modernization Act of 1997, companies could not use a health claim or nutrient-content claim in food labeling unless the FDA published a regulation authorizing such a claim. Two new provisions of FDAMA now permit distributors and manufacturers to use such claims if they are based on current published authoritative statements from certain federal scientific bodies, or from the National Academy of Sciences. These provisions are intended to expedite the process by which the scientific basis for such claims is established, and they place dietary supplements on an equal footing with conventional foods. 

The FDA and the FTC have a long-standing agreement governing the division of responsibilities between the two agencies. With regard to dietary supplements, the FDA has the power to  

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The 1997 Food and Drug Administration Modernization Act (FDAMA) specifically recognizes the right of a licensed pharmacist to compound pharmaceutical products in response to, or in anticipation of an appropriate prescription. The Act also authorized the establishment of an FDA Expert Advisory Committee... 

Food laws, British, 23 160-161. See also Food Additives Amendment of 1958 Food and Drug Administration Modernization Act of 1997 (FDAMA) Food Chemicals Codex (FCC) Food Quality Protection Act of 1996 (FQPA) Food manufacturing aids, 12 66-67... 

TABLE 2.2. Summary of the Contents of the 1997 Food and Drug Administration Modernization Act... 

The Food and Drug Administration Modernization Act of 1997, Pub. Law 105-115, 127, 1997. National Association of Boards of Pharmacy, Good Compounding Practices Applicable to State Licensed Pharmacies, Park Ridge, IL, 1993. 

The Food and Drug Administration Modernization Act reauthorizes PDUFA and mandates accelerated reviews and regulates drug advertising of unapproved uses. 

The paediatric drug testing provisions in the Food and Drug Administration Modernization Act of 1997 had an automatic 5-years sunset limitation. In January 2002, Congress enacted the... 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

The results of clinical trials conducted under an IND have traditionally been regarded as confidential business information that FDA was prohibited from releasing to the public under the Freedom of Information Act and that the publication of which was determined solely by the drug sponsor. The Food and Drug Administration Modernization Act of 1997 established a clinical trial data bank for drugs for serious or life-threatening disease and required the inclusion of information on all effectiveness trials for these drugs. As a result of widespread concern about the lack of public availability of information about all clinical trials and their results, individual companies and the Pharmaceutical Research and Manufacturers of America have... 

Food and Drug Administration (1997) Section 111 of Title I of the Food and Drug Administration Modernization Act of 1997 [section 505A of the Federal Food, Drug, and Cosmetic Act (21U.S.C.355a). 

The BLA was established pursuant to the Food and Drug Administration Modernization Act of 1997, consolidating a prior requirement for two applications a Product License Application and an Establishment License Application. The final implementing rule reduced the amount of information a manufacturer is required to file in its BLA application and shifted responsibility to the plant inspection process to ensure that manufacturers complied with cGMP standards. 

The Food and Drug Administration Modernization Act (FDAMA) of 1997, which was implemented in February of1998, also altered the PAI process. The act significantly altered the balance of authority within the FDA. At the time the inspection program was implemented, FDA field offices were... 

In the mid-1990s, FDA and the EU began discussions to harmonize cGMP-type inspections. Specifically, in 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA), which amended the FDC Act, to encourage FDA to support the Office of the U.S. Trade Representative, in consultation with the Secretary of Commerce, in... 

Clinical Trials Data Bank We have established a clinical trials data bank to collect information on your clinical trials protocols. Please list your protocols for serious and life-threatening conditions [Food and Drug Administration Modernization Act of 1997 section 113]. When finalized, you should list your protocols in accordance with our Draft Guidance for Industry—Information Program on Clinical Trials for Serious or Life-Threatening Diseases Implementation Plan, June 2001. 

Pharmacoeconomic and quality of life claims Claims that a product is cost-effective, or that it will improve an individual s quality of life, may be made so long as there is proof. There is no firm standard for how such proof must be documented. In the case of pharmacoeconomic claims, the Food and Drug Administration Modernization Act of 1997 said that companies can provide cost-effectiveness information to managed care and other purchasing or reimbursing organizations, so long as the claims were based on competent and reliable information. This was intended to be a lesser standard than the usual one that... 

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