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Monographs take years to develop and aren't able to be updated whenever new research or safety issues emerge.<br><br>Congress recognized that the OTC monograph system was not up to today's needs, and that it required an innovative and responsive transparent regulatory structure. It passed the CARES Act, which provides a framework to allow FDA to make changes to OTC monographs for drugs outside of the notice-and-comment rulemaking process, and also allows flexibility to the review process for OTC products to better meet changing consumer needs.<br><br>The CARES Act gives FDA authority to issue administrative orders (OMORs) that add or subtract GRAS/E-related conditions for OTC drugs. These orders can be made by industry or FDA.<br><br>When an OMOR is sent to the FDA the order will go through public comment and then be examined by the FDA. 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This includes the ones that are sold by major pharmaceutical companies. If a generic drug maker creates a product that is in violation of the patent, the brand name company can sue the maker. The lawsuit could stop the generic drug from being sold for as long as 30 months.<br><br>A generic drug may also be made if it contains an active ingredient that is similar to the brand-name drug. In this instance, the generic drug is referred to as an abbreviated new drug application (ANDA).<br><br>There are also ways that devices or drugs could be approved quickly, if it is shown to provide significant benefits over existing drugs or devices. These include Fast Track and Breakthrough Therapy designations.<br><br>The FDA's accelerated approval process permits it to review drugs that treat serious illnesses and meet medical needs that are not being met. To accelerate the review of these medications, the FDA can employ surrogate endpoints, such as a blood test to expedite the process instead of waiting for clinical trial results.<br><br>The FDA also has a program that permits manufacturers of drugs to submit a portion of their applications as they become available instead of waiting for the whole application. This is known as rolling submission and reduces the time to get approval. It can also help save costs by decreasing the number of drug trials required for approval.<br><br>FDA Investigational New Drug Application (INDs).<br><br>An IND application must be made by a company that wants to conduct a clinical study of unapproved drugs. 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The IND must also include details on the procedure for delivery to the recipient as well as test results for sterility and pyrogenicity for parenteral drugs.<br><br>(b) The IND must include a section that describes the manufacturing process and experiences of the investigational drug. This includes any previous testing of human subjects carried out outside of the United States, any animal research or published materials that may be relevant to the safety or the reason for the proposed use.<br><br>In addition to these elements in addition, the IND must describe any other information FDA must review including technical or safety information. These documents must be provided in a format that can be evaluated, processed, and archived by FDA.<br><br>During the course of an IND investigation Sponsors must report any unexpected life-threatening or fatal suspected adverse reactions as soon as they can, but in no case later than 7 calendar days following the first time the sponsor received the information. They must also submit any reports of foreign suspected adverse reactions. These reports must be reported in a narrative format on a FDA form 3500A or electronically to be reviewed, processed and archived.<br><br>Marketing Claims<br><br>A product might claim to be better or more efficient than a competitor in marketing. Claims may be based on an opinion or scientific evidence. Whatever claim is being made, it should be clear and in line with the brand's identity.<br><br>Advertising and promotions are subject to the supervision of the Federal Trade Commission (FTC) and the Food and Drug Administration. 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