The Food and Drug Administration approval process begins with preclinical development demonstrating that the product is reasonably safe for use in humans and showing "pharmacological activity" that warrants further research clinics. (FDA, 2010) Rodents, pigs, and canids are commonly used to validate safety and efficacy in laboratory studies due to their human-like anatomy. (Sivaramakrishan, 2010) The next step in the process is submitting an Investigational New Drug Application (IND) to the FDA for several reasons. (FDA, 2010) Current federal law requires a drug to be part of an approved marketing application prior to transportation and distribution to clinical research sites across state lines. (FDA, 2010) Manufacturers are also required to suspend clinical trials for thirty consecutive days so that the FDA can review the application and ensure there are no unnecessary risks. (FDA, 2010) There are three different types of IND; which are investigator, emergency and treatment. (FDA, 2010) An IND investigator is often “referred” by a physician who initiates and performs clinical trials on an unapproved drug or on a drug approved for a new purpose or different circumstances. (FDA, 2010) An emergency new drug trial request is intended to clinically use an investigational drug in an urgent situation, such as cancer, that leaves no time for a thorough FDA review. (FDA, 2010) The third type is the application of experimental drugs for treatment; its aim is the presentation of investigational drugs that have potential in prior clinical evaluation for serious life-threatening situations. (FDA, 2010) A new drug trial application is required to verify......middle of paper......DA, brand-name drugs and their pharmaceutical equivalents have met accurate identity criteria, strength, quality, purity, and potency which includes commercial production. (FDA, n.d.) Current Good Marketing Practice (CGMP) regulations impose minimum requirements for the methods and facility controls used in the manufacturing, processing, and packaging of the pharmaceutical product. (FDA, 2011) The purpose of these regulations is to ensure safety, maintain the integrity of ingredients at the declared concentration, and maintain honesty regarding labeling. (FDA, 2011 and Siedman, 2000) The regulations were initially ratified in 1963 and were continually revised due to accidents, injuries, deaths, and technological advances. (Siedman, 2000) Verification of compliance is carried out through unannounced inspections of facilities, analysis of samples and examination of previous history. (FDA, 2011)