Agents seized $24 million in unapproved guaifenesin and time-released treatments from KV Pharmaceuticals. In case you missed it here's the news that appeared today. The company is disposing of these supplies. Watch local news coverage here.
Representative Dingell and Senator Grassley have big plans for an FDA overhaul, and expanded powers for the Agency. More from the Wall Street Journal. But one persistant question: Why must the Agency still oversee both food and drugs? Drugs are challenging enough as it is, and getting more challenging by...
Dr. Von Eschenbach is back in the wood shed. This week, Reps Dingell and Stupak sent the FDA a letter (click here to read) demanding responses and more information, and alleging that the Agency might have been aware of GMP compliance issues involving some Ranbaxy products sold in the U.S.,...
The story, click here for our version (one of thousands circulating) ----which explains the Valentine's Day inspections at Ranbaxy's U.S. headquarters last year--- has been generating a lot of buzz this week. Also mentioned in the allegations is Parexel Consulting, the consulting arm of contract manufacturer Parexel, which had a...
Spoke briefly with one, Michael Kowolenko, SVP of biopharmaceutical manufacturing at Wyeth, who talked about the industry’s fear of change, why it exists and offered some suggestions on what to do about it. Below are some (raw) audio snippets of the interview.
At a session on Wednesday afternoon, Richard Friedman of CDER discussed FDA and foreign inspections of manufacturing sites, and mentioned proposed solutions that would harmonize requirements and lighten the load, while maintaining standards. They include a global system of surveillance and mutual inspectorate acceptance.
One of the greatest complaints about ISO standards is that, in the wrong hands, they can "certify" mediocre, or even poor business practices. Allowing the industry to regulate itself probably won't work, as research has suggested.
Ever see the old Abbott and Costello "who's on first" baseball routine? "I don't know" was on third base. Pharma is not the only industry that suffers from less-than-perfect supply chain risk management, as Juran Institute CEO Joe De Feo pointed out in a recent audio interview.
OK, Rockville's a long way from Miami...but the analytical detective work that FDA, MIT scientists and some companies did into potential root causes of heparin contamination makes a great whodunit. C&EN, an outstanding publication, beat us to it by several months with this gem, published in late November.
We all know that physicians must distance themselves from patients to keep from becoming too emotionally involved in each case. Perhaps this applies to drug development and manufacturing as well, and industry profesionals may risk viewing adverse patient reactions as a mere statistic.