FDA websites

The FDA website with the Agency guidance on these topics can be found at ... 

There are a number of FDA websites (many are listed under the reference section of this chapter) which provide the most current information regarding the approval process. Excerpts related to the approval process (at the time of publication) from several of the FDA websites are provided below. 

Consideration of the proposed indications for the candidate drug together with knowledge of its pharmacokinetics and metabolism in healthy volunteers will indicate whether specific studies in patients with impaired hepatic or renal function will be needed to be included in the Marketing Approval Application and NDA. Useful relevant guidelines are available on the FDA website and it is advisable to discuss proposals with the relevant regulatory authorities. The topic is considered in more detail in Chapter 5. 

Approved quinolones as of February 2006 Generic available Marketed in the United States by Oscient. Source. U.S. Food and Drug Administration (FDA) website www.fda.gov/cder... 

QA/QC specifications are summarized in the Chemistry, Manufacturing, and Contois (CMC) section and in the Established Description sections of the Biologies License Application (BLA) for every recombinant and other biologic product. Additional details on FDA requirements for product specification and QA/QC standards are found in the Guidance for Industry (FDA website— www.fda.gov/cber/guidelines.htm). 

Drug interactions at FDA website http //www.fda.gov/cder/drug/ druginteractions/default.htm (to be active in 2006). 

MAPP) for processing the botanical submissions in CDER has also been published for the application sponsors and the Agency review staff to follow. Information on the new MAPP and the BRT will be presented in the following pages, which can also be found in the FDA website (1). 

For details of the Guidance, the readers are referred to the official FDA website for botanical drug review (1). 

This chapter has discussed the CGMP regulations and some of the more important guidances. There have been a number of additional guidance documents related to GMPs published by the FDA. These documents are all posted on the FDA website. They are listed below along with their URL ... 

Pharmaceutical nonactive excipients have long been applied in a variety of pharmaceutical dosage forms to provide a wide range of functional characteristics that facilitate the optimal delivery of a drug to achieve the desired therapeutic effects. Pharmaceutical excipients are inert materials with no adverse effects on the safety and efficacy of therapeutic products. The Food and Drug Administration (FDA) website (1) provides a database listing all the FDA-approved nonactive pharmaceutical excipients. This provides formulation scientists a useful reference for efficient choices of the suitable excipients for the desired formulations of drug. 

The development of a new drug involves extensive preclinical (animal) and clinical (human) studies.19,21 The basic procedure for testing a new drug is outlined here and is summarized in Table 1-2. Details about the phases of drug testing can also be found on the FDA website (http //www.fda.gov/cder/handbook). 

Freedom of Information Act warning letters are available on the FDA Website (currently linked at http //www.fda.gov/foi/warning.htm). 

FDA warns consumers to discontinue use of botanical products that contain aristolochic acid , FDA [website] (ii Apr. 2001) (http //vm.cfsan.fda.gov/ -dms/addsbot.html) J. Kelly, Chinese herb leads to kidney failure, cancer , WebMD Medical News Archive [website] (7 June 2000) (http //my.webmd. com / content / article /36 /172.8 582.70)... 

Drug Safety and Quality Centre for Drug Evaluation and Research, Report to the Nation, FDA [website] (2002) (http //www.fda.gov/cder/reports/ rtn. /2002/rtn2002-3.htm)... 

The American FDA website gives background information on resistance with a worldwide perspective ... 

FDA regulatory guidances, FDA website for regulatory guidances. www.fda.gov / cder / guidance/index.htm). 

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