July 23, 2008
 

Avastin (bevacizumab)


Avastin (bevacizumab)
Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination.

Pet Food Products Seized at PETCO Distribution Center
Consumers who bought animal food products from PETCO in 16 states should take certain precautions

Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic.

FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007.

FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.

Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007.

Subscribe to Posts [Atom]