NEW REPORT PRESENTS FDA's FOCUS ON GLOBAL COOPERATION FOR PRODUCT SAFETY The U.S. FDA Commissioner Margaret A. Hamburg, MD released the Agency's "Global Engagement Report" detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. This report describes the steps the Agency is taking to ensure the imported food, … [Read more...]
TOP POSTINGS FROM THE BLOG OF BARRY A FRIEDMAN, PHD
A RESPONSE TO YOUR QUERIES RE: FREQUENT TOPICS OF INTEREST Periodically, I am asked what are the most frequent topics which interest the reader. Because the reader has so many varied interests, it is difficult to determine this without retrospectively reviewing the data. I have summarized below the “top six” topics that have been viewed since the beginning of 2012. You may … [Read more...]
FDA’S CHINA OFFICE FOCUSES ON REGULATORY ACTIVITIES (4/4/12)
FDA DESCRIBES ON-GOING INSPECTION AND ANALYTICAL CAPABILITIES “Our primary duties have been to build relationships with FDA’s regulatory counterparts and to work with Chinese firms that want to export products to the United States,” states Christopher Hickey, Ph.D. who leads the FDA's 13-person staff in China. The office also aims to increase the number of inspections at … [Read more...]
IMPORT ALERT FINDING GREATER USAGE WITHIN FDA’S BAG OF “WEAPONS”
GULF PHARMACEUTICAL INDUSTRIES (02/23/12), NOBILUS ENT (03/07/12) and LABORATORIOS JALOMA S.A. de C.V. (03/9/12) ALL RECEIVE IMPORT ALERTS WITHIN ONE MONTH AS PART OF THEIR WARNING LETTERS The FDA has recently begun to use within their CDER Warning Letters the following terminology on a frequent basis. This includes … [Read more...]
WINTAC LIMITED INDIA RECEIVES FDA WARNING LETTER (022312)
CITES ASEPTIC MANUFACTURING FACILITY FOR SIGNIFICANT cGMP VIOLATIONS Specific violations observed during the inspection include, but are not limited, to the following: 1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. Such procedures shall include validation of … [Read more...]
