FDA notifications
NucliSens HIV-1 QT is approved
In November, the Food and Drug Administration approved NucliSens HIV-1 QT, developed by bioMerieux, Inc., of Durham, NC. NucliSens HIV-1 QT is used in conjunction with clinical presentation and other laboratory markers of disease progression for prognostic assessment of HIV-1 infected patients and for monitoring the effects of antiretroviral therapy by serial measurements of plasma HIV-1 RNA for pediatric and adult patients with baseline viral loads greater than 93,000 and 28,000 copies of HIV-1 viral RNA/mL respectively.
For more information, visit the web site www.fda.gov/cber/pma/P0100010.htm.
New director appointed for FDA’s DAVDP unit
Debra Birnkrant, MD, has been appointed division director for the FDA’s division of antiviral drug products division (DAVDP). Since joining DAVDP in 1989, she has served as medical officer, team leader, deputy division director, and acting division director. She received her undergraduate degree in biology and a medical degree from Temple University. Birnkrant did her internal medicine internship and residency at the Georgetown-VA program in Washington, DC. Since joining FDA, she has continued her clinical work at the VA in internal medicine/primary care and most recently at the Whitman-Walker AIDS Clinic.
Birnkrant has been active in many areas that the DAVDP has oversight of and has been particularly instrumental in leading the agency’s topical microbicides team.