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...]
NEW ENGLAND COMPOUNDING CENTER (NECC) DECLARES BANKRUPTCY
The CBS Evening News (12/21, story 9, 0:25, Pelley) reported "The specialty pharmacy linked to that deadly meningitis outbreak filed for chapter 11 bankruptcy protection today." NBC Nightly News (12/22, story 7, 0:25, Holt) added that the Framingham, Massachusetts-based specialty pharmacy "is facing 130 … [Read more...]
FDA APPROVES RAXIBACUMAB TO TREAT INHALATION ANTHRAX (12/14/12)
FIRST MONOCLONAL APPROVED UNDER FDA'S ANIMAL EFFICACY RULE The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or … [Read more...]
HEMOFARM A.D., VRSAC, SERBIA, RECEIVES WARNING LETTER (6/20/12) FOR ASEPTIC PROCESSING ISSUES
EXAMINE HOW THE REVISED USP<1116> RELATES TO THESE OBSERVATIONS FIRM IS PLACED UNDER FDA IMPORT ALERT Hemofarm A.D., Vrsac, Serbia recently received a four Observation Warning Letter for unreliable environmental (to include microbiological) monitoring data. Several of the CGMP violations listed in their letter include … [Read more...]
AMERIDOSE, LLC RECEIVES 15 OBSERVATIONS AS PART OF FORM FDA 483 (11/09/12)
SISTER COMPANY OF NECC RECEIVES TWENTY PAGE 483 CONTAINING SEVERAL REPEAT OBSERVATIONS COMMENT The FDA conducted an inspection of Ameridose, LLC, Westborough, MA from October 10 through November 9, 2012. The investigation, involved fourteen Investigators and three microbiologists including one microbiologist from CDER. A total of fifteen Observations including several … [Read more...]
