Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of Drug Submissions and Applications....more
In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more
On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more