Brand Name Versus Generics

The Food and Drug Administration’s approval process initiates with preclinical development that demonstrates that the product is reasonably safe for use in humans and that it shows “pharmacological activity” that warrants further clinical research. (FDA, 2010) Rodents, swine, and canines are commonly used to validate safety and effectiveness in laboratory studies due to their similar anatomy to that of humans. (Sivaramakrishan, 2010) The next step in the process is the submission of an Investigational New Drug Application (IND) to the FDA for several reasons. (FDA, 2010) Present federal law mandates that a drug be part of an endorsed marketing application ahead of transportation and distribution to clinical research sites across state lines. (FDA, 2010) Manufacturers are also required to halt clinical studies for thirty consecutive days for the FDA to review the application and make assurances that there are no unnecessary risks. (FDA, 2010) There are three different types of INDs; which are investigator, emergency and treatment. (FDA, 2010) An investigator IND is often “submitted” by a clinician that both commences and performs clinical studies on an unendorsed drug or an approved drug for a new purpose or different circumstances. (FDA, 2010) An emergency investigational new drug application is for the purpose of clinical using an experimental drug in an urgent situation, such as cancer, that does not allow time for thorough FDA review. (FDA, 2010) The third type is a treatment investigational drug application; its purpose is for the submission of experimental drugs that have potential in previous clinical assessment for severe life –threatening situations. (FDA, 2010)

An investigational new drug application is required to con...

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...DA, branded drugs and their pharmaceutical equivalents have met thorough criterion for identity, strength, quality, purity, and potency which includes commercial production. (FDA, nd) Current Good Marketing Practice (CGMP) regulations dictate minimal requirements for facility methods and controls used in the manufacture, processing, and packaging of the drug product. (FDA, 2011) The purpose of these regulations is to ensure safety, maintain the integrity of the ingredients at the claimed strength, and preserve honesty with regards to labeling. (FDA, 2011 & Siedman, 2000) Regulations were initially ratified in 1963 continually revised due to accidents, injuries, fatalities, and technological advancements. (Siedman, 2000) Verification of compliance is down by unannounced inspections of facilities, sample analyses, and examination of preceding history. (FDA, 2011)