Well, I have been wrong before and I was wrong last week when I said we probably saw our last snowfall here inside the Beltway. We had another dusting mid-week. I will probably be wrong again someday. But while we all hold our breath on that front, let’s review some of what happened this week that we haven’t already talked about.
- Update to the Approvable Letters Listing – Under the Resources by Me column on the left side of the blog, I have finally updated the list of companies that have received approvable letters since October, 2006.
- Senate Finance Committee Calls for FDA Accountability on Post-Marketing Reporting – A report issued by the Breckenridge Institute in November 2006 that termed the system that the FDA employs for tracking post-marketing adverse events as "dysfunctional" has prompted Chair Max Baucus to send a letter to Dr. Andrew von Eschenbach to provide a response to the report by April 2.
- New Hypertension Drug Approved – The agency announced the approval of Tekturna (aliskiren) tablets for the treatment of high blood pressure, or hypertension, which affects an estimated 25 percent of Americans and causes increased risk of stroke, heart attack, kidney failure, heart failure and death. Tekturna is manufactured by Novartis Pharmaceuticals Corp
- FDA Approves First Fully Automated Test to Screen for West Nile Virus in Blood and Tissue Donors – The FDA issued a release announcing the approval of a license supplement for the first fully automated West Nile Virus (WNV) nucleic acid test for donor screening. The Procleix WNV Assay on the Procleix TIGRIS system is licensed to detect the virus’ genetic material in plasma specimens from individual donors of blood, tissue and organs, and other living donors. It is not intended for use on cord blood specimens or as an aid in the diagnosis of WNV infection. The Procleix WNV Assay on the Procleix TIGRIS system is manufactured by Gen-Probe Inc. and is marketed by Chiron Corporation.
- FDA Publishes Guidance on Communication of Drug Safety Information – The FDA issued a Guidance on communicating drug safety this week. The FDA now has set up an index to drug-specific information that allows one to access safety information where an asterisk next to a drug name indicates an active safety alert. It is not new information, but it is organized differently. However, there was some serious criticism of this guidance in the blogosphere. Check out John Mack’s posting of March 6 entitled "Drug Safety – A Mere Asterisk to the FDA".
Now you all have a good weekend!