February is American Heart Month
The US Food and Drug Administration marked Valentine’s Day with an informative blog post about cardiovascular health: Heart disease is the leading cause of death in the United States. One in…
Author: Matthew Tanner
FDA Budget for 2013 Reflects Increased Reliance on Industry User Fees
The recently unveiled federal budget proposal for 2013 allocates no new money for the US Food and Drug Administration. The proportion of the agency’s budget that comes from user fees (collected…
Comment Sought on ClinicalTrials.gov Registration Burden
The US National Institutes of Health is soliciting public comments on its estimate of the time and effort required to register a study on ClinicalTrials.gov. While there is no specific deadline,…
New FDA Consent Requirement Becomes Mandatory on March 7, 2012
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…
Antiparasitic Drug Use and Resistance in Ruminants and Equines; Public Meeting; Request for Comments
Docket No. FDA–2012–N–0102 The Food and Drug Administration (FDA) is announcing a public meeting entitled “Antiparasitic Drug Use and Resistance in Ruminants and Equines.’’ The purpose of the meeting…
Nature Profiles John Cutler, Lead Investigator of 1940s Guatemala Experiments
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…
NPR Story Offers Patient Perspectives on Clinical Trials
A recent story on National Public Radio’s Talk of the Nation featured an interview with Mary Elizabeth Williams, a writer for Salon who took part in a clinical trial of a new…
Request for Information (RFI): Input into the Deliberations of the Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research
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…
What’s Happening With InfoEd Clinical Trials?
The need for robust clinical trial management systems has never been greater than it is today. The changing realities of research – increasingly complex protocols, tighter timelines, and less forgiving…
Menlo Report Comments Deadline Approaching
February 27, 2012, is the deadline to submit public comments on the Menlo Report outlining recommendations for the ethical conduct of information and communication technology research. Building on the framework of the…