Federal Register notice: FDA makes available a draft guidance entitled Material Threat Medical Countermeasure Priority Review Vouchers.
Federal Register notice: FDA announces the availability of a draft guidance entitled Product Title and Initial U.S. Approval in the Highlights of Pres...
AuroMedics Pharma recalls one lot of levofloxacin in 5% dextrose injection 250mg/50mL in a single-use flexible container after it was found to contain...
FDA approves a Qiagen PMA supplement extending the indications for use of the companys Therascreen EGFR companion diagnostic to guide the use of Boehr...
A just-concluded FDA inspection cites PharMediums Cleveland, MS manufacturing facility for repeated inspectional observations from earlier agency insp...
FDA grants Enzychem Lifesciences an orphan drug designation for EC-18 for treating acute radiation syndrome caused by bioterrorism.
A revised HHS contingency staffing plan reveals a higher number of FDA staff would stay on the job than earlier estimated if a government shutdown is ...
FDA issues a guidance on content and format for two sections in labeling for human prescription drug and biological products.