Notifications on Data Integrity
FDA notifications for industry on data integrity.
FDA to pharmaceutical companies: Certain studies conducted by Raptim Research Pvt. Ltd. are unacceptable
FDA has identified significant data integrity and study conduct concerns with bioequivalence and bioavailability studies conducted by Raptim Research Pvt.…
Study Data Technical Conformance Guide – Technical Specifications Document
This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.
UPDATED MEETING DATE AND PUBLIC PARTICIPATION INFORMATION: May 5, 2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement – 05/05/2025
May 5, 2025: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug…
Meetings, Conferences, & Workshops | Drugs
Meetings, conferences, and workshops sponsored or co-sponsored by Center for Drug Evaluation and Research.
Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration – 04/29/2025
The workshop will clarify the intent of FDA recommendations for IVPT studies, with step-by-step demonstrations illustrating how IVPT study procedures…
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…