Withdrawn and Expired Guidances | Drugs

A blocked manometer port on the Ambu SPUR II resuscitator may delay ventilation or cause barotrauma

C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of their applicability, opportunities, and challenges.

Information about the mission and objectives of FDA’s Drug Development Tool (DDT) qualification programs.

Trividia recommends that device users who receive an E-5 error code and are experiencing symptoms of high glucose should seek medical care immediately  

Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to present).