FDA warns Suzhou Pharmaceutical about significant deviations from CGMP for APIs.
Ropes & Gray attorneys summarize provisions in an FDA final guidance on post-market cybersecurity risk prevention and mitigation.
Covington & Burling reviews issues raised in CDRH 2016 Warning Letters on medical device reporting.
The Supreme Court agrees to hear appeals from Sandoz and Amgen on key provisions of the Biologics Price Competition and Innovation Act.
FDA releases a new draft guidance on Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers dealing ...
One of president-elect Donald Trumps candidates for leading FDA deletes his Twitter posts, presumably to block the public from learning his thoughts a...
Federal Register Notice: FDA makes available a draft guidance on Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Dev...
FDA publishes a draft guidance to tell biosimilar sponsors how the agency will determine a products interchangeability with a reference product.