The holidays have left little time for posting, but here is at least getting in the Weekly Roundup. Hopefully, however, with the respite that is to come, there will be time to build up some editorial content. In the meantime, between eating too many cookies and consuming too rich of holiday fare, there has been a burst of activity from FDA – perhaps as everyone gets ready to head out for the holiday.
- Agency Approves First Pathogen Reduction System to Treat Plasma – Blood products can carry a degree of risk to transmit pathogens to the recipient that can be serious and even life-threatening, including HIV, hepatitis and West Nile Virus, among others. This week FDA announced approval of Cerus Corporation’s Intercept Blood System which was found to be effective in reducing a broad range of viral and bacterial pathogens. It works by utilizing a photochemical process that involves a controlled exposure to ultraviolet light and amotosalen, a chemical that facilitates the inactivation process and the plasma is then purified to remove the chemical and any byproducts. You can learn more in the company’s press release.
- FDA Announces Pharmacy Compounding AdComm – The subject of pharmacy compounding has been an active one over the past two years that culminated in the passage of legislation giving FDA new regulatory authority. To that end, one of the newest development is the appointment of an advisory committee on compounding, the members of which were announced by FDA this week. The complete roster is available with links to their CVs. A timeline has been assembled of compounding developments on a tab on the Eye on FDA site.
- CHD Predictor Cleared – The agency announced this week that it had cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events for use in all adults with no history of heart disease. Almost two-thirds of women and half of men who die suddenly from CHD have no previous symptoms. The PLAC test for Lp-PLA measures the activity of a biological marker for vascular inflammation – lipoprotein-associated phospholipase A2 (Lp-PLA2) – which is a condition associated with the buildup of plaque in the arties that supply blood to the heart resulting in a narrowing of the arteries.
Once again reminding folks that President Obama has made the 26th a holiday for federal employees and so for those watching for PDUFA decisions on or around that date, please take note. That’s it for me this week – off to finally get those presents bought, wrapped and sent! Have a wonderful weekend.
Photo of new baby Holsteins Courtesy of Anne Becker