CDER Data Standards Program
CDER Data Standards Program
Data Standards Program Strategic Plan and Board
The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program…
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis. Monitor liver…
Analysis of Testosterone Esters in Serum and DBS Samples—Results From an Interlaboratory Study
An interlaboratory study was conducted to compare the detection capabilities of testosterone esters in blood matrices. Serum-, cellulose- and polymer-based…
Consumer Updates
Science-based health and safety information you can trust.
CDER Conversations
Interviews with experts from FDA’s Center for Drug Evaluation and Research (CDER) on priorities, projects, and initiatives.
Commemorating the 15th Anniversary of the Biologics Price Competition and Innovation Act
FDA expert discusses the Biologics Price Competition and Innovation Act
Approvals & Reports
FDA publishes a list of first-time approvals to manufacture generic drugs and a variety of reports on generic drug application…
NIH Funded Pediatric Labeling Changes for drugs studied under the 409i process
Section 409i of BPCA requires NIH and FDA to prioritize therapeutic areas in critical need of pediatric research. NICHD then…
Notices of Updates
Webpage providing notices of updates to FDA’s STIC webpages for antibacterial and antifungal drugs.