SHOULD THE FDA BE DOING MORE? Recently the New England Compounding Center (NECC) was found to have dispensed a number of syringes containing methylprednisolone acetate to treat pain control and inflammation. Following a number of reports from various states, the FDA and CDC became involved in attempting to locate the source of … [Read more...]
DPT LAKEWOOD, LLC LAKEWOOD, NJ RECEIVES FDA WARNING LETTER (08/27/12) FOR STERILITY FAILURES
DPT Lakewood, LLC was inspected between February 15 through March 7, 2012. During this audit the FDA found that Santyl Ointment to be adulterated and that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP. Specific violations observed … [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’S CONTRIBUTION TO THE DRUG SHORTAGE CRISIS” — A HOUSE OF REPRESENTATIVES STAFF REPORT (6/15/12)
The U.S. House of Representatives Committee on Oversight and Government Reform recently published a 21 page staff report document that was highly critical of the FDA. Several of you had requested information regarding this report since you were interesting in reading the report that caused the FDA response. Enclosed below are several of the key … [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...]
