-
Daniel Schultz, MD, acting director of the FDAs Center for Devices and Radiological Health (CDRH) since April, last month had the acting term removed from his title by acting FDA Commissioner Lester Crawford. In announcing the appointment of Schultz to head CDRH, the agencys medical device unit, Crawford said he brings to our medical device program the ideal combination of skills, experience and temperament to ensure that FDAs medical device program is second to none.
-
-
The FDA has approved a combination of 2 antiretrovirals, abacavir and lamivudine, for the treatment of HIV-1 infections. Each tablet contains 600 mg of abacavir and 300 mg of lamivudine for once daily administration. The combination is marketed by GlaxoSmithKline as Epzicom.
-
The FDA has approved a 5-nitroimidazole for the treatment of trichomoniasis, giardiasis, and amebiasis. Tinidazole, a second-generation nitroimidazole antiprotozoal agent, is marketed as Tindamax by Presutti Laboratories.
-
GEMINI Trial; CAMELOT Trial; INVEST Trial; The Dangers of Vitamin E; FDA Actions.
-
-
-
In a survey of 365,000 records of patients followed by general practitioners in Holland for at least 1 year during a 7-year period, 5551 incident cases of pneumonia developed. Users of acid suppression, particularly proton pump inhibitors (PPIs), had a 4.5 fold increased unadjusted risk of pneumonia, compared to untreated controls.
-
Wild poliovirus (WPV) was imported into 8 countries that were previously felt to be polio-free in west Africa (Benin, Burkina Faso, Cote dIvoire, Ghana, Togo) and Central Africa (Cameroon, Central African Republic, Chad) from January 2003 to March 2004.
-
The Centers for Disease Control (CDC) has confirmed the diagnosis of rabies in 4 recipients of transplanted organs and their common donor. All 4 transplant recipients presented with rapidly progressive encephalitis within 21 to 27 days after receiving their transplant and all subsequently died.