An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….
Real World Evidence
Sex Differences in Infectious Diseases
Women and men are different in many aspects when it comes to disease-causing pathogens. An interesting fact is that...
The COVID-19 Adverse Event Dashboard
The FDA’s adverse event reporting system (FAERS) is a web-based tool that allows users to interactively search and...
Real World Evidence in the MedTech Industry
Real World Evidence (RWE) is playing an increasingly significant role in the medical device industry. The FDA has...
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