An in-depth McClatchy News article explores the fears of some public health officials that FDAs haste to authorize some tests and treatments for the c...
TherapeuticsMD asks FDA to issue product-specific guidance putting restrictions on applications for a generic form of Imvexxy.
Former FDAer Thomas Laughren says improved patient selection for schizophrenia drug clinical trials could reduce the problem of increasing placebo res...
FDA issues an immediately-in-effect guidance relating to the new requirement for medical device manufacturers to notify FDA about certain changes in t...
FDA warns Englands Bedfont Scientific about Quality System violations in its manufacturing of carbon monoxide gas analyzers.
FDA releases its latest batch of Warning Letters that includes Bedfont Scientific, Philosys and Shriram Institute for Industrial Research.
FDA revises a 3/26 guidance entitled Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
Pfizer and BioNTech say that the first participants have been dosed in the U.S. in a Phase 1/2 clinical trial for their BNT162 vaccine program to prev...