US Food and Drugs Administration

The US Food and Drug Administration (FDA) is required by the US Federal Food, Drug, and Cosmetic Act to regulate drug products in the United States. Its role is to ensure that drugs are developed, manufactured, and marketed in accordance with regulatory requirements so that they are safe and effective. The FDA has four centers and a regulatory office  

Exhibit 7.2 presents a brief history of the FDA. For the purpose of regulation of drugs, the relevant centers are the CDER and CBER. 

The FDA started from a single chemist in the US Department of Agriculture in 1862, with the appointment of Charles M. Wetherill by President Lincoln. By 2001, it had a staff of about 9100 and a budget of 1,294 billion. The FDA now has employees from diverse disciplines, including chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, and lawyers. 

About a third of the agency s employees are stationed outside the Washington, DC area in over 150 field offices and laboratories, including five regional offices and 20 district offices. 

The three categories of drugs regulated by the CDER are the following  

We will follow up in Chapter 8 to examine more closely the regulatory processes for testing, trialing and approving a drug for marketing. 

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US Food and Drug Administration, Code of Federal Regulations 21, 1995. 

US Food and Drug Administration. Challenge and Opportunity on the Path to New Medical Products, March, 2004, http //www.fda.gov/oc/initiatives/critical-path/whitepaper.html... 

Akron Research Commercialization Corp. has recently disclosed a drug candidate based on Ag-NHC complexes (Silvamist ). These NHC complexes were proven efficient for the treatment of respiratory diseases, and the company is currently applying for Investigational New Drug (IND) status with the FDA (US Food and Drug Administration)... 

The Library of Chemical Information is maintained by the US Food and Drug Administration s Center for Food Safety and Applied Nutrition and is an excellent database for multiple classes of chemicals including food additives, cosmetics, colour additives, pesticides and other chemicals. 

One major problem caused by Section 409 (c) (3) of the Federal Food, Drug and Cosmetic Act, commonly known as the Delaney Clause , which governed the registration of pesticides was the statement, No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal,... . Dr Fred R. Shank, Director, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, in... 

US Food and Drug Administration, Federal Food, Drug and Cosmetic Act (Amended 1997). Also available on the World Wide Web http //www.fda.gov/opacoiii/laws/fdcact/fdctoc.htm. 

The process of development and validation of animal drug residue methods for US Food and Drug Administration regulatory use... 

The US Food and Drug Administration (FDA) evaluates methods to be used in government regulatory laboratories for the determination and confirmation of drug residues in food derived from animal products. The FDA Center for Veterinary Medicine (CVM) oversees the validation (i.e., demonstration that the method is suitable for use) via a protocol known as a method trial. CVM ensures that the appropriate government laboratories have the tools needed to monitor the Nation s food supply. 

The Pesticide Analytical Manual of the US Food and Drug Administration or the Official Methods of Analysis of AOAC International are method collections with international recognition. Both compilations are written in English, one prerequisite for its success. Method collections of EU Member States are most often available only in the national languages. Eor this reason, they are relatively unknown in other Member States. Fortunately, some good collections of official national methods are translated into the English language. The most important are... 

Pesticide Analytical Manual. Volume 1, Multiresidue Methods, third edition, US Food and Drug Administration Washington, DC, Sect. 302 (1994). 

Subsequently the medication was approved for self identified African Americans by the Federal Drug Administration (FDA), the first time a medication was approved for a specific racial group (US Food and Drug Administration, 2005). This combination was then marketed as BiDil. The approval led to a great deal of controversy and discussion, much of it critical, about the FDA decision. The findings from these trials, however, provide evidence that ethnicity can make a difference in clinical treatment response (Sankar 8c Kahn, 2005). 

US Food and Drug Administration (2005). FDA approves BiDil heart failure drug for Black patients. Press Release, June 23, 2005. www.fda.gov/bbs/topics/NEWS/2005/NEW01190.html [Accessed October 4,2005]. 

An excellent example for an enzymatic resolution process is reported for production of Pregabalin. This drug was approved by the US Food and Drug Administration (FDA) in 2004 against neurophatic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Several different routes have been developed based on asymmetric hydrogenation, crystallization and biocatalytic resolutions [16-20]. The most powerful and currently applied process is based on a lipase resolution, shown in Figure 14.3. This process is one of the very few... 

CDER Guidance for Industry. SUPAC-IR Immediate-Release Solid Oral Dosage Forms Scale-Up and Post-Approval Changes Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation US Food and Drug Administration, 1995. 

Oxytetracycline is a broad-spectrum antibiotic, which has been used worldwide in veterinary medicine and in aquaculture for the prevention and treatment of disease and as feed additives to promote growth. The maximum residue limits (MRLs) of OTC and relative substances as described by the US Food and Drug Administration [66] and European Union [67] are presented in Table 4. 

USDA (2001) Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-cut Produce. US Food and Drug Administration, Center for Food Safety and Applied Nutrition, September 30, 2001. www.cfsan.fda.gov... 

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