Federal Register notice: FDA publishes a list of information collections that have been approved by the Office of Management and Budget.
In a move that may signal the agencys increasing reliance on real world data, FDA reverses its decision to require TherapeuticsMD to submit additional...
FDA releases a guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.
Federal Register notice: FDA makes available a guidance on Formal Dispute Resolution: Sponsor Appeals Above the Division Level.
Federal Register notice: FDA makesavailable a revised draft guidance entitled ANDAs: Pre-Submission of Facility Information Related to Prioritized Gen...
FDA Review posts FDA-related Federal Register notices for the week ending 11/3/2017.
CDRH Office of Compliance director Robin Newman leaves the agency to pursue an undisclosed opportunity.
FDA clears a Medacta International 510(k) for its 3DMetal Tibial Cones for knee revision surgery.