The Food and Drug Administration

The FDA was founded in 1930. An act of Congress officially established it as a governmental agency in 1988, and it now forms a part of the US Department of Health and Human Services. The FDA Commissioner is appointed directly by the President (with the consent of the US Senate). 

Drugs chemical-based, biologies, and biopharmaceuticals Blood supply and blood products Cosmetics/toiletries Medical devices 

Advertising and promotional claims relating to the above product types 

The major FDA responsibilities with regard to drugs include  

The criteria used by the CBER and CDER regulators in assessing product performance during the drug development process are similar, i.e. safety, quality and efficacy. However, the administrative details can vary in both name and content. Upon concluding preclinical trials, all 

Biopharmaceutical products have not fallen neatly into either category and the decision to refer any biotech-derived drug to CBER or CDER is taken on a case-by-case basis. Tissue plasminogen activator (tPA Chapter 9), for example, is licensed as a biologic, whereas erythropoietin (EPO Chapter 6) comes under the auspices of CDER. The majority of biopharmaceuticals, however, are assessed by CBER. 

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With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. 

Pood and Dmg Administration, History Office, A Guide to the Resources on the History of the Food and Drug Administration, GPO, Washington, D.C, 1995. 

A primary responsibility of the Food and Drug Administration (FDA) is the enforcement of the Federal Food, Dmg, and Cosmetic Act of 1938 and its various amendments, eg. May, 1976, in which dental materials, instmments, and equipment are included. Premarketing clearance requirements apply for estabhshing the safety and effectiveness of new products. There is a close Haison between the FDA and the ADA standards and certification programs. 

The importance of the penicillins as a class of heterocyclic compounds derives primarily from their effectiveness in the treatment of bacterial infections in mammals (especially humans). It has been estimated that, in 1980, the worldwide production of antibiotics was 25 000 tons and, of this, approximately 17 000 tons were penicillins (81MI51103). The Food and Drug Administration has estimated that, in 1979 in the U.S.A., 30.1 x 10 prescriptions of penicillin V and 44.3 x 10 prescriptions of ampicillin/amoxicillin were dispensed. This level of usage indicates that, compared to other methods of dealing with bacterial infection, the cost-benefit properties of penicillin therapy are particularly favorable. Stated differently, penicillin treatment leads to the elimination of the pathogen in a relatively high percentage of cases of bacterial infection at a relatively low cost to the patient in terms of toxic reactions and financial resources. 

Hygiene and Regulation Almost unique to MF is the influence of regulatoiy concerns in selec tion and implementation of a suitable microfilter. Since MF is heavily involved with industries regulated by the Food and Drug Administration, concerns about process stabihty, consistency of manufacture, virus reduc tion, pathogen control, and material safety loom far larger than is usually found in other membrane separations. 

In 1984 the use of nitrile resins was re-approved by the Food and Drugs Administration with speeifie limits on the level of residual unreacted monomer. 

Note that some treatment operations choose a pollution prevention technique to dispose of the float. This involves feeding the float to animals. When this is done for the situation where the feed animals are used for human consumption, organic compounds such as chitosan, carrageenan, lignosulfonic acid,or their derivatives can be used. Use only compounds that are approved by the Food and Drug Administration (FDA) Office of Veterinary Medicine. 

The Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics it is housed in tlie Department of Health and Human Services and reports to tlie Assistant Secretary for Health. 

For food and pharmaceutical applications, the microbial count must be reduced to less than 10,000 viable cells per g exopolysaccharide. Treatment with propylene oxide gas has been used for reducing the number of viable cells in xanthan powders. The patented process involves propylene oxide treatment for 3 h in a tumbling reactor. There is an initial evacuation step before propylene oxide exposure. After treatment, evacuation and tumbling are alternated and if necessary the reactor is flushed with sterile nitrogen gas to reduce the residual propylene oxide level below the Food and Drug Administration permitted maximum (300 mg kg 1). The treated polysaccharide is then packaged aseptically. 

Because there are a limited number of antiviral drug s and more than 200 viral diseases, the primary health care provider may decide to prescribe an antiviral drug for an unlabeled use even though documentation of its effectiveness is lacking. Approval by the Food and Drug Administration (FDA) is necessary for a drug to be prescribed. On occasion, the use of a drug for a specific dis-... 

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

A copy of this report is routinely sent to the Institute for Safe Medication Practices (ISMP), to the manufacturer.labeler, and to the Food and Drug Administration (FDA). USP may release my identity to (check boxes that apply)... 

Recycled bottles are regulated by the Food and Drug Administration. Chemically recycled bottles are allowed to come into contact with both liquid and solid food products. 

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

Methyl parathion is approved only for use on crops. The maximum amount of methyl parathion residue allowed by the Food and Drug Administration (FDA) and EPA on crops used as food is 0.1-1 ppm. The FDA has monitored the food supply for pesticides for a number of years. FDA purchases many kinds of foods through Market Basket Surveys and analyzes them for residue levels of pesticides. These FDA studies allow scientists to estimate the daily intake of pesticides. Generally, the FDA monitoring studies conclude that the U.S. food supply contains only very small amounts of pesticides that are not a concern. However, there have been some reports of the illegal use of methyl parathion inside homes. For more information, see Section 1.7 and Chapter 6. 

Two forms of pegylated IFN-a have been approved by the Food and Drug Administration (FDA) and by the European Medicines Agency (EMEA) for the... 

All samples are from The Dow Chemical Co. except 3a and 4d, which are from the Food and Drug Administration. 

Another important aspect for discussion is the impact of regulations, spe-cihcally the regulation on electronic document management and electronic signatures, 21 CFR Part 11, published by the Food and Drug Administration (FDA) for the hrst time in 1997 [1] (also see Chapter 26, which covers 21 CFR Part 11 in detail). Since that time the draft rules of Part 11 have been withdrawn and reissued along with various guidance documents [2-3], Some of the key points of Part 11 are as follows ... 

The file may be queried In response to questions from clinical staff at the National Institutes of Health and physlr-clans and laboratory scientists throughout the country who submit their problems by letter or telephone The file has been used to provide Information for a pharmaceutical manufacturing company preparing a new drug application to the Food and Drug Administration For the latter organlzatloi the file has been... 

The federal government develops regulations and recommendations to protect public health. Regulations can be enforced by law. Federal agencies that develop regulations for toxic substances include the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), and the Food and Drug Administration (FDA). 

Since 1999, when the Food and Drug Administration allowed the first health claim for soy-fortified foods in the USA, there has been a large increase in the sales of food products claiming to contain soy isoflavones. At the same time, over-the-counter supplements have become widely available. However, concerns have been raised about the real health benefits of such supplements in the absence of adequate information about bioavailability, pharmacokinetics and safety. To fill this gap, an extensive study on pure isoflavones and commercial soy isoflavone supplements has recently been carried out (Setchell et al, 2001). A selection of 31 commercially available supplements showed a wide variation in isoflavone composition and in the amount provided by one tablet. Furthermore, a lower isoflavone content, with respect to the claimed levels, has been observed in almost 50% of the analysed products. In one case, no isoflavones at all could be detected (Setchell et al, 2001). 

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

Colorants were the first food additives subjected to governmental regulation in the United States (US). After successive toxicological evaluations, the Food and Drug Administration established a list of permitted colorants and lakes. Only 7 synthetic pigments (and 2 others with restrictions) and 6 of their lakes are now permitted as food colorants in the US while 17 are permitted in the European Union (EU) see Table 7.3.L - ... 

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