ORA Laboratory Manual Introduction The Laboratory Manual is a reference manual for ORA laboratory personnel and supporting units. It provides personnel with information on internal policies […]

Summary Company Announcement Date: May 28, 2024 FDA Publish Date: May 29, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of particulate […]

On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007.  This new law represents […]

Recognizing the necessity of reauthorizing PDUFA before the end of FY 2002 to assure continuity of operations, Congress enacted the Public Health Security and Bioterrorism Preparedness […]

Speech by Robert M. Califf, M.D., MACC (Remarks as prepared for delivery) I am delighted to once again help kick off this important conference. Its focus […]

Pharmaceutical quality provides the confidence that a patient’s next dose of medicine is safe, effective, and available when it’s needed. When CDER receives a prescription drug […]

For Immediate Release: May 28, 2024 Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat […]

Recognized Interpretive Criteria   Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm)Under Review Pathogen S I R S I R Staphylococcus aureus M100 standard is recognized Enterococcus […]

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]