Significance of FDA approval
FDA approval refers to the formal endorsement by the U.S. Food and Drug Administration, confirming that a medication or treatment is safe and effective for public use. This process includes evaluations of clinical trial results and is crucial for the marketing of new drugs, ensuring they meet necessary safety standards. FDA approval is vital for a variety of products, including medications like ertugliflozin, Remdesivir, and many others, highlighting the importance of regulatory oversight in healthcare.
Synonyms: Market authorization, Authorization, Sanction, Validation
The below excerpts are indicatory and do represent direct quotations or translations. It is your responsibility to fact check each reference.
The concept of FDA approval in scientific sources
FDA approval is the official authorization by the U.S. Food and Drug Administration confirming the safety and efficacy of medications or treatments, exemplified by the approval of ADALIMUMAB and tolvaptan for specific health conditions.
From: World Journal of Pharmaceutical Research
(1) Phenytoin was approved by the FDA in 1953 for use in seizures.[1] (2) The authorization granted by the U.S. Food and Drug Administration for a drug to be sold and marketed.[2] (3) The authorization granted by the Food and Drug Administration for medications, such as tirzepatide that combines GLP-1RAs with GIPRA.[3] (4) The Food and Drug Administration's endorsement of Remdesivir for emergency use in treating COVID-19.[4] (5) The process by which the Food and Drug Administration grants authorization for a drug, such as baricitinib, based on evidence of its safety and efficacy.[5]
From: The Malaysian Journal of Medical Sciences
(1) The regulatory approval status indicating that IVIG is sanctioned for specific therapeutic uses; the study notes significant off-label use as well.[6]