In response to increasing reports of abuse and misuse of propylhexedrine, we reviewed several sources of data. These included calls to U.S. poison control centers, case […]

  Get Smart About Antibiotics Use antibiotics only for infections caused by bacteria Learn more Antibiotics are drugs that fight infections caused by bacteria NOT viruses. […]

Committee’s Official Designation Pulmonary-Allergy Drugs Advisory Committee Authority The Pulmonary-Allergy Drugs Advisory Committee (the Committee) is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, […]

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 […]