FDA Believes Now is the Time to Remove the Bug from Pharmaceutical Manufacturing The FDA recently published an article wherein they discuss the rationale for removing B. cepacia from the pharmaceutical arena. They cite a number of reasons why they believe that this bacterium and its variants should no longer be permitted. These discussions are … [Read more...]
NUSIL TECHNOLOGY LLC RECEIVES FDA WARNING LETTER (032312)
API MFG CITED FOR OOS AND MICROBIOLOGICAL ISSUES (B. cepacia) -- REFERENCES RECENT PDA J. PHARM SCI & TECH 1. Your firm failed to have an adequate out-of-specification (OOS) procedure to conduct thorough and scientifically sound investigations including corrective actions. For example, the OOS report number (b)(4) for lot (b)(4) of Simethicone Emulsion USP … [Read more...]
FDA RELEASES “GLOBAL ENGAGEMENT REPORT” (4/23/12)
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...]
