Federal Register notice: FDA makes available a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment.
The House Oversight Committee puts pressure on FDA and its oversight of imported Chinese and other foreign active pharmaceutical ingredients and finis...
FDA warns Dr. Kevin Bender, doing business as DBC Research in Tamarac, FL, about violations in his conduct of clinical trials.
Endo is ordered to pay $1.85 billion in fines and forfeitures after pleading guilty to introducing misbranded Opana ER into interstate commerce and cl...
FDA warns Chinas Bioptimal International about multiple violations at a Singapore facility manufacturing two unapproved catheters.
Federal Register notice: FDA announces that CDRH Office of Product Evaluation and Quality has modified its organizational structure.
FDA approves an AB therapeutic equivalence code for cancer drug paclitaxel suspension and tells HBT Labs it must formally apply for a return of PDUFA ...
Federal Register notice: FDA issues an order permanently debarring Adam Paul Runsdorf over his felony conviction for conspiring to distribute counterf...
