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...]
FDA WORKS WITH VARIOUS VENDORS DURING SANOFI PASTEUR’S INABILITY TO PRODUCE THERACYS BCG DUE TO BIOLOGICAL PRODUCT SHORTAGE
COMMENT The FDA is often criticized because it is viewed as creating biological and drug product shortages when it issues a FDA 483, Warning Letter, Consent Decree or executes a seizure. This Alert published by the FDA demonstrates several of the actions that the FDA may initiate to minimize these shortages. In addition, the FDA now typically adds a "boilerplate" paragraph … [Read more...]
FDA (CBER) ISSUES ELEVEN PAGE 483 TO SANOFI PASTEUR (04/25/11)
COMMENT CBER issued to Sanofi Pasteur an eleven page, 32 Observation Form FDA 483 following an audit of their Toronto, Canada facilities. The dates of inspection encompassed the time frame of April 10 - 25, 2012. CBER previously published the Warning Letter regarding this subject which was initially noted within this Blog earlier in the week. The most significant … [Read more...]
