Day: November 16, 2017

In the 21st Century Cures Act, FDA is required to accept Real World Evidence (RWE) in support of market approval decisions. However, the RWE is based off the Real World Data (RWD) which is highly variable and hence could impact the acceptability of RWE derived from such RWD. One of the most sought-after RWD is … Read more

Last week FDA announced initiatives that would reduce the direct regulation of most general health genetic tests citing low risk of such tests. A new study published this week raises concerns about incorrect genetic tests of this kind citing specific clinical outcomes linked to the false results. General Health Risk (GHR) tests are designed to … Read more