The FDA is a federal agency within the United States Department of Health and Human Services responsible for protecting and promoting public health by regulating and supervising food safety, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation-emitting devices, veterinary products, and cosmetics.
The process of adhering to the rules, regulations, and standards set forth by the FDA to ensure that products related to healthcare, including food, drugs, and medical devices, are safe, effective, and accurately labeled.
The series of steps that pharmaceutical companies must undergo to gain FDA approval for new medications, including preclinical studies, clinical trials, and submission of a New Drug Application (NDA) or Biologics License Application (BLA).
The FDA’s oversight of medical devices, ensuring they meet safety and efficacy standards before they can be marketed and sold to healthcare providers and consumers. This includes everything from simple devices like bandages to complex machinery like MRI machines.
The requirement for manufacturers, healthcare professionals, and consumers to report any negative or unexpected effects associated with the use of a food, drug, or medical device to the FDA, enabling continuous monitoring of product safety.
FDA guidelines governing the content and format of labels and packaging for food, drugs, and medical devices to ensure accurate representation of ingredients, dosage, usage instructions, and potential risks.
FDA regulations that outline the minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, packaging, and storage of pharmaceuticals, medical devices, and food products to ensure quality and safety.
The ongoing monitoring of products after they have been approved or cleared by the FDA, including surveillance of adverse events, product defects, and other safety concerns, to identify and address potential risks.
A regulatory mechanism by which the FDA can expedite the availability of medical products during public health emergencies, such as pandemics or bioterrorism threats, based on limited data demonstrating safety and efficacy.
The process by which the FDA removes or corrects products from the market that violate laws governing safety and effectiveness, typically due to concerns about contamination, mislabeling, or adverse effects. Recalls can range from voluntary actions by manufacturers to mandatory actions ordered by the FDA.