The FDA is responsible for not only drugs and biologics, but their regulatory authority also extends to food, medical devices, veterinary drugs, cosmetics, nutrition products, and radiation devices. Thus, they are responsible for protecting the health of the nation's citizens across a broad spectrum, including such areas as labeling of the nutritional content on food, approving only drugs found to be safe and effective for human or veterinary use, the allergenic potential of cosmetics, and the certification of mammography equipment. FDA further interprets new laws from Congress and promulgates regulations and guidelines for the industry to follow.
From the perspective of the pharmaceutical industry, the agency is first and foremost involved in the evaluation of drugs and biologics, at both the investigational phase and later at the approval phase. No investigational drug or biologic may enter into a clinical trial without review by the FDA to ensure that adequate testing has occurred in animals that would predict a reasonable safety/efficacy profile worthy of exposing human subjects. Likewise, no drug or biologic may enter into commercialization without the review and approval of FDA.
It is the clear intent of FDA to approve only those products that have a risk/benefit ratio that is considered acceptable.
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