About FDA - What is the FDA? About Food and Drug Administration
What is the FDA? The Food and Drug Administration (FDA), the oldest consumer protection agency in the United States, plays a crucial role in maintaining public health by regulating food safety and human and veterinary drugs.
Medical devices, cosmetics, and radiation-emitting products Additionally, the FDA provides reliable science-based health information to the public, especially those interested in health care, and pharmaceutical sectors closely follow FDA approval processes, as this can significantly affect the market value and revenue potential of companies involved in drug development.
Without FDA approval, drugs and other regulated products cannot be sold in the United States. The FDA's responsibilities span across the US and its territories, including Puerto Rico and Guam. Its tasks involve monitoring food quality, ensuring the safety and effectiveness of medical products, and enforcing labeling standards for cosmetics and dietary supplements.
About Food and Drug Administration
The agency also advances public health by encouraging medical innovations, setting up regulations for clinical trials, and establishing comprehensive testing requirements for new drugs. Historically, the FDA's regulatory role originated in 1906 with the Pure Food and Drug Act gradually expanding with societal legal and technological advancements.
The FDA's drug approval process involves multiple stages, from initial animal testing to final inspections of manufacturing facilities. The process begins with animal testing followed by an investigational new drug application to assess the drug's toxicity.
Once approved, clinical trials are conducted, leading to a new drug application NDA, which includes exhaustive research data.
FDA then reviews the NDA, conducts facility inspections, and if satisfied, grants approval, allowing the drug to enter the US market for small-cap healthcare companies. FDA approval can be transformative, directly impacting stock performance and investor sentiment, as it enables the company to proceed with commercialization, shaping the trajectory of their financial success.
