The Food And Drug Administration Essay

848 WordsFeb 15, 20164 Pages
The Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical device in context to granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, post-marketing surveillance of the medical product, etc. The Pharmaceutical companies seek for FDA approval for a new drug to be marketed through a long process. This process starts with applying an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that drug is safe effective. On the other hand, there are many patients unable to enroll in a trial because of exclusion criteria or because the study is for a different indication.However, when patient unable to enroll in a clinical, patients may be able to receive the product, when appropriate, through the Expanded access. Legal arguments and implications:- (i) On 2009, the FDA promulgated a program called the “Expanded access” or“Compassionate use” ( 21 CFR 312.1) which allows the patients to have an access to a Investigational Medicinal product which is subjected to Investigational New Drug (IND) application (according to an IND 21 CFR 312.8). The FDA in 2009 revised the regulation of “Expanded access” because there was no clear regulation related to different types of patients, and the access to

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