FDA says it will recognize drug manufacturing inspections from eight European countries, avoiding duplication of inspections and resources.
As a condition of approval, FDA is requiring that AstraZeneca conduct additional studies to verify and describe anticipated clinical benefits of Calqu...
CDRH associate director Suzanne Schwartz says the agency works with medical device manufacturers to address cybersecurity issues.
Attorney Serra Schlanger says New Jersey is considering a proposal to restrict drug company payments and gifts to healthcare professionals with author...
FDA clears an Abbott 510(k) for its Alinity ci-series instruments for clinical chemistry and immunoassay diagnostics.
The Government Accountability Office says HHS needs a better way of assessing the effectiveness of its efforts to combat the opioid addiction crisis b...
FDA releases its latest batch of Warning Letters that includes Accelerated Analytical Laboratories, Aztex Enterprises and Kim Chemicals Private.
Three House members raise concerns about FDA oversight of a Bayer post-marketing study of its Essure birth control device that appears to be behind sc...