FDA CIRCULAR NO. 2010-005, February 17, 2010

[ FDA CIRCULAR NO. 2010-005, February 17, 2010 ]

SUBMISSION OF PROCESS FLOW IN HANDLING ADVERSE EVENTS FROM DRUGS, MEDICAL DEVICES, FOOD SUPPLEMENTS, MILK PRODUCTS, HERBALS, ETC.

Relative to the strengthening program for pharmacovigilance, all companies are di- rected to submit their official protocols or flowcharts on how adverse events are handled by the company. Submit the said protocol or flowchart on or before March 02, 2010.

For strict compliance.

Adopted: 17 Feb. 2010

(SGD.) NAZARITA T. TACANDONG, RPH., MPA Acting Director IV