What evidence FDA requires for drugs and biologics
How FDA evidence standards work for NDAs, 505(b)(2) applications, ANDAs and biologics licenses, including accelerated approval and the animal rule.
Tag: evidence
5 posts
What one assay has to prove under FDA and under the IVDR
How FDA classification and special controls compare with IVDR performance evaluation in the evidence a single in vitro diagnostic has to generate.
What evidence the EU requires for medical devices
How Regulation (EU) 2017/745 sets the clinical evidence for a CE marked device, covering clinical evaluation, investigations, equivalence and PMCF.
What evidence FDA requires for medical devices
What must be proven under each FDA device marketing route and the kinds of study that satisfy 21 CFR parts 807, 814 and 860.
Analytical validity, clinical validity and clinical utility
How 21 CFR Part 862 special controls separate analytical performance, clinical performance and claims about patient management for in vitro diagnostics.