The US Food and Drug Administration has released a new draft guidance clarifying IND requirements for radioactive drugs used in positron emission tomography scanning. Clinical use after June 12, 2012, will require an approved marketing application or an expanded access…

From the White House website: Strengthen National Preparedness for All Hazards, Including Naturally Occurring Threats and Intentional Attacks. The Budget includes $547 million to enhance the advanced development of next generation medical countermeasures against chemical, biological, radiological and nuclear threats.…

The US Food and Drug Administration has issued a guidance document explaining a new requirement to include language about ClinicalTrials.gov in consent forms for drug and device studies. Consent forms for covered studies that begin on or after the implementation deadline of…

Nature recently published a news feature on the US Public Health Service experiments in Guatemala and other officially sanctioned efforts during the 1940s to fight STDs. Letters written by Dr. John Cutler show that he and others involved in the research knew…

From the NIH: The Council of Councils has established a working group to provide recommendations to the Council on: (1) implementing the guiding principles and criteria contained within the Institute of Medicine report, “Chimpanzees in Biomedical and Behavioral Research: Assessing…

The National Academy of Sciences (NAS) has released a report entitled “A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials”, available here.  This report sets out a conceptual framework for environmental, health, and safety research on nanomaterials,…