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If you're curious about FDA and its operations, read on for more details in this Mytour article.
What is FDA? How does it operate?
FDA, an abbreviation for Food and Drug Administration, is the regulatory agency for food and drugs in the United States. Established in 1906, it is responsible for safeguarding and promoting public health through regulations and oversight of food safety, tobacco products, dietary supplements, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation-emitting devices, and veterinary products.
In addition, the FDA develops its own rules, including those related to clinical trials, applicable to all types of new drugs. Pharmaceutical companies must undergo a four-phase clinical trial process before introducing their drug products to consumers.
According to the FDA, the agency oversees the safe consumption of healthcare products, food, and tobacco products valued at over 2.4 trillion USD. In 2016, the budget for the FDA was approximately 4.7 billion USD.
The relationship between the FDA and specific investors involved in biotechnology and pharmaceutical companies is significant. FDA approval is crucial for companies developing new drug products. Without the agency's approval, products regulated by the FDA cannot be legally marketed in the U.S. market.
Approval and Management Process of FDA for Food and Drug
Companies developing and selling new drugs must obtain approval and consent from the FDA before marketing these products to consumers.
FDA is responsible for overseeing and reviewing manufacturing facilities producing regulated items, including but not limited to vaccine and drug manufacturers, blood banks, food processing facilities, dairy farms, livestock feed processing companies, and pharmaceutical companies.
Additionally, the agency is responsible for inspecting animal testing facilities and conducting clinical trials, approving products before they are introduced to the market. Imported products must also undergo FDA testing and approval before they can be shipped internationally.
The regulatory agency issues product recall notices in collaboration with local companies and partners. The recall may be due to inaccurately declared components posing risks to consumers.
In this article, Mytour introduced FDA to you and its operations. Additionally, readers can explore other articles on Mytour to learn about the abbreviations of major global organizations such as WB, IMF, WTO, UN, EU, and WHO. Find out their full English names, and more.
