Newsletter - November 16, 2017
Can False General Health Genetic Tests Hurt the Consumer?
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. Read More
Real World Testing Data and FDA Acceptance of Real World Evidence
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. Read More
Can False General Health Genetic Tests Hurt the Consumer?
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. Read More
Real World Testing Data and FDA Acceptance of Real World Evidence
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. Read More
