This week, the Senate is debating, not only PDUFA reauthorization but much publicized bills that would increase FDA's oversight of drug safety, with provisions for labelling, DTC advertising limits and requirements for post-approval safety surveillance. To watch a video update which aired on Bloomberg yesterday, click here.
While IT talks about Web 3.0, we poor mortals in the publishing business are still struggling with Web 2.0, but Peter Rost's Question Authority, Pharmalot and Pharmagossip all report that AstraZeneca's CEO is ready to investigate illicit sales and marketing practices stemming from the "Buckets of Money" scandal.
Disposable bioprocess equipment eliminates cleaning and cleaning validation requirements, offering substantial potential savings for manufacturers. As a result, interest is growing in the technologies, and an industry association, the Bioprocess Systems Alliance, has been established to advance best practices, move toward standards and examine safety issues that one doesn't find...
The Commissioner appeared on C-SPAN yesterday, addressing the petfood recall, food safety, but also drug safety and funding (beginning at 16:34), risk vs. benefit analysis and Merck's Arcoxia. Here's the link to the Real Player file.
Last week, an expert had suggested that the wheat used in the contaminated pet food might have been intentionally adulterated, and melamine added to improve the protein levels recorded by NIR, thus ensuring a higher price. Melamine polymer isn't toxic but monomer is.
The Chinese government's official news service reports that the nation is taking steps to secure its vaccine and plasma-based drug supplies. By the end of last month, its FDA equivalent, the State Food and Drug Administration, had sent over 80 supervisors to 33 plasma drug manufacturing facilities in 24 locations.