As a result, they need product, labeling that differentiates their drug from those already marketed. Marketing has to selleck compound provide creative concepts for the prescribing physician, the patient, and the company’s senior management. They also have to make sure that, budget goals arc met. It is not uncommon for the marketing group to have differences of opinion from both the clinical and regulatory groups within their own company, as well as with the FDA.

Legal In order for a drug to be financially successful, patent protection Inhibitors,research,lifescience,medical is a key element. The legal group must submit patents at the appropriate time and do all in its power to avoid lawsuits from potential competitors. The legal group also ensures that neither the FDA nor the Federal Trade Commission (FTC) will challenge advertising and promotional materials. Food and Drug Administration Inhibitors,research,lifescience,medical Hie FDA’s primary mission is to protect public health by regulating the food supply, drugs, devices, and cosmetics. The FDA regulates through the FDCA, Title 21 of the Code of Federal Regulations

(CFR)2 and publications in the Federal Register,3 and by issuing guidance and other regulatory documents. Development philosophy Don’t waste time: time is money Time is a key factor in drug development. With finite patent lives, the quicker a drug gets to the market, the longer the revenue stream will be free of generic competition. Therefore, in order to minimize the development time, the team should: Plan carefully. Inhibitors,research,lifescience,medical Execute meticulously. Replan when necessary. Do only what is needed. Hire people who want to get the job done. Have pride in their Inhibitors,research,lifescience,medical product. Working with the FDA Structure of the FDA There are four FDA centers that have the potential to interact, in drug development. These are the Center for Drug Evaluation and Research

(CDER), Center for Biologies Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), and Center for Food Safety and Applied Nutrition (CFSAN). With the advent of drug-delivery devices and dietary Inhibitors,research,lifescience,medical supplements that, can sometimes appear to be drugs, the boundaries between the centers can at times be unclear. As a result, it, is always a good idea to know which center will review a particular product. Sources of information MRIP There are several sources from which information can be obtained about the FDA. Through the Freedom of Information Act,4 the United States government has established a mechanism to obtain information directly from the FDA, which is otherwise not easily accessible through publicly available information. The FDA can be contacted via letter or fax. The FDA also has research services and can provide, on a fee-for-service basis, specific information located within their archives. Commercial companies also provide information services. With the creation of the Internet, public information is more readily available than ever before. The FDA has a web site for each of its divisions with a sophisticated search engine and document services (http://www.