Alternative spellings: pre-market approval application, premarket approval application An application made by the manufacturer to the Food and Drug Administration (FDA) for approval to market a medical product in the United States. Note: This application includes the pertinent information documenting the safetySyn.: absolute risk reduction (Related concepts: number need... and effectivenessSyn.: clinical effectiveness. and assess that impact." си... of the product.
and • provides information on costs and financial impact. Note 2: The report may optionally discuss organisational considerations. Note 3: A “mini-HTA(Related concept: PubMed) An electronic database of medical ...” may be as rigorous as an HTA report but typically has a restricted scope and so is quicker to produce. Note 4: Related terms include health technologyAlternative spelling: gray literature The documents publishe...technology assessment(Related concept:health technology). "The application of sci..., HTA report, rapid reviewAlternate spelling: randomised controlled trial A study comp..., level of evidence(Related concept: equity) The principle of fairness that sta....»