Understanding FDA Literature Review Requirements The FDA requires literature reviews to ensure that regulatory decisions are based on solid scientific evidence. This isn't just about compiling papers; it's about systematically searching, appraising, and synthesizing published data to demonstrate safety, efficacy, and compliance. These requirements span multiple domains, from drug approvals to medical devices and health…
At the ISPOR 2024 Conference in Atlanta, attending health economics and outcomes research (HEOR) professionals lamented the drudgery of systematic literature reviews (SLRs) as they envisioned the potential for generative artificial intelligence (GenAI) to fix it. With a single SLR estimated to take anywhere from six to 16 months to complete and cost an average…
