This week I posted on the listing of approvable letters for 2007. This proved an immensely popular posting, I am happy to say and happy for the emails I received from folks. One item of note, I did get an update from one reader which I am adding to the list today that includes one approvable letter that seems to have slipped by me.
Events of this week move onward, and there were plenty of events this week to fill 10 blogs. Here are just a few of them:
- FDA Inspects Wrong Chinese Plant – Oops, our bad. During what is not a good week for the FDA, following an announcement by the FDA of allergic reactions to Baxter’s Heparin it is revealed in the news that the FDA inspected the wrong Chinese plant that manufactured an ingredient of Heparin. Though there is no link established between the ingredient and the reactions of patients to the Heparin about which the FDA issued an alert, the revelation is sure to shake up agency critics on the Hill, as evidenced by the statement of Rep. Rosa DeLauro, D-Conn., chairwoman of the House Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee who likened the FDA with the Keystone Cops in an ABC Evening News piece this week.
- New Hemophilia Treatment Licensed - The agency has licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free. It is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia and is also licensed to help prevent surgical bleeding in this patient population. Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in Philadelphia.
- FDA Issues Guidance on Off-Label Use – The agency issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. According to the press release, "Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion." The FDA welcomes public comments on the draft guidance.
- New Resources – I want to draw your attention to two new items I’ve just come across that appear to be very good resources. The first is eHealthnews.com – The First European Health News Portal that has a wide range of resources available including white papers on various topics. Check it out. The second is a new site called World Pharma News which appears to aggregate a lot of global current news.
That’s it for this week. Once again, thanks for the response on the approvable letters. And have a good, safe and warm weekend.