The Use Of Fda Regulation Of Drug Industry And Its Impact On Marketing

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INTRODUCTION Human drugs are regulated by the U.S Food and Drug Administration (FDA). One of the first legislation which authorized FDA to regulate drugs was “Pure Food and Drugs Act” enacted in 1906. In last century, role of FDA has significantly increased in terms of regulation and supervision of drugs to promote and protect public health. The historical evolution of FDA regulation of the drug industry and its impact on marketing unapproved drugs will be discussed later in this memorandum. The term “drug” is defined means “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man” by “affecting the structure or any function of the body of man.” In order to be marketed, “new drug” needs to have an approved application. “New Drug” can be defined as “any drug…the composition of which is such that such drug is not “generally recognized as safe and effective” for their labelled use. Prescription drug are prescribed by a physician, usually bought at pharmacy, prescribed for and intended to be used by one person and regulated by FDA through the New Drug Application (NDA) process. A typical NDA approval process includes three clinical phases which are distinct in terms of number of patients, length of study and purpose. The new drug application approval process helps in maintaining certain safeguards such as drug safety, dosing, manufacturing quality control standards, review of ongoing clinical safety and efficacy data,

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