It is the abbreviation for the U.S. Food and Drug Administration (FDA), one of the executive agencies established by the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public **** Health (PHS).
As a scientific regulatory agency, the FDA is responsible for ensuring the safety of food, cosmetics, drugs, biologicals, medical devices, and radiological products manufactured in or imported into the United States.
It was one of the first federal agencies whose primary function was to protect consumers. The agency is relevant to the lives of every American citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries seek and receive help from the FDA to promote and monitor the safety of their products.
Expanded Information
The U.S. FDA drug safety certification is flawed:
1. A recent study led by researchers at Yale University shows that passing the FDA safety certification doesn't mean that a marketed drug is absolutely safe, and that one out of every three FDA-approved medications will be approved within a few years of approval. develop new safety problems.
2. 32% of new drugs have safety problems after approval. These drugs are rarely withdrawn, and the FDA usually issues "black box warnings," or warning letters, to let doctors and patients know about new safety information and to warn people about the increased risks of using the drug.
3. The FDA relies on data from preliminary drug tests and clinical trials to assess the safety and effectiveness of new drugs, but most trials involve fewer than 1,000 test subjects and a trial period of six months or less, making it difficult to detect safety problems that might be found when the drug is used over a longer period of time.
4. There is a need for continuous post-marketing surveillance of newly approved drugs. At the same time, they also emphasized that while the study results show flaws in the FDA's safety certification efforts, they do not negate the validity of the FDA's current efforts.
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