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Biogen plant that makes older MS drugs fails FDA inspection
Posted: Tue Dec 10, 2013 2:42 am
by MSUK
Biogen plant that makes older MS drugs fails an FDA inspection
Biogen Idec may impressing Wall Street with its new Tecfidera treatment for multiple sclerosis, but the drugmaker is not impressing regulators with some of its practices for manufacturing a pair of older treatments – Tysabri and Avonex............ Read More -
http://www.ms-uk.org/MSnews
Re: Biogen plant that makes older MS drugs fails FDA inspect
Posted: Tue Dec 10, 2013 5:56 am
by HarryZ
MSUK wrote:Biogen plant that makes older MS drugs fails an FDA inspection
Biogen Idec may impressing Wall Street with its new Tecfidera treatment for multiple sclerosis, but the drugmaker is not impressing regulators with some of its practices for manufacturing a pair of older treatments – Tysabri and Avonex............ Read More -
http://www.ms-uk.org/MSnews
Hey come on...let's not be too harsh on Biogen....they have to cut costs somehow since Tysabri hasn't come close to earning them the $$$ they hoped to make !!!!
Harry
Re: Biogen plant that makes older MS drugs fails FDA inspect
Posted: Tue Dec 10, 2013 1:16 pm
by NHE
A recent inspection report issued by the FDA, which examined a facility last summer, noted that the drugmaker did not always challenge the validity of all testing results provided in certificates of analysis as part of qualification procedures. In other words, Biogen (BIIB) did not always ensure that active pharmaceutical ingredients were sterile, as suppliers claimed.
In addition, Biogen did not adequately or completely document control procedures to demonstrate that procedures are followed, and the FDA found at least one questionable instance concerning cleaning and sanitizing. There are further details in the 483 inspection report, which you can read here.
http://www.fda.gov/downloads/AboutFDA/C ... 377864.pdf