Often the question is asked "what were your top postings during the previous year. This is an intriguing question since I don't know myself until I review the postings at the end of each year. With an accumulation of over 70,000 views, it is of interest to determine what you, the viewers, deemed to be the most important. I have now sorted through the … [Read more...]
MOST FREQUENTLY VIEWED POSTINGS — YEAR TO DATE FROM THE BLOG OF BARRY A FRIEDMAN, PhD
Periodically individuals have contacted me to learn of the "most frequently viewed postings" on my Blog. On occasion, I ask myself the same question. As a result I am posting the "top six" requested sites for your review. You may find one or more of these postings of interest to you. Each of these remains available and is easy … [Read more...]
FDA COMMENTS ON ITS ACTIONS INAPPROPRIATELY RESULTING IN SHUTDOWN OF MANUFACTURING FACILITIES (JULY 2012)
FDA recently commented on the report entitled “FDA’s Contribution to the Drug Shortage Crisis” for the Honorable Elijah E. Cummings. Within this letter from Jeanne Ireland, Assistant Commissioner for Legislation, she lays out the FDA’s response to specific questions that Mr. Cummings asks about Drug Shortages and whether the FDA contributed to them. His letter includes: “The … [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...]
CURRENT CONTRACT MANUFACTURING OPERATION (CMO) REGULATORY ISSUES (3/15/12)
FEATURING A SUMMARY OF BEN VENUE ISSUES Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of both Contract Manufacturing Operations (CMOs) and in-house sterile manufacturers — especially injectables. There has been a greater oversight and detailed review of all protocols and processes. Any issue or potential … [Read more...]
