FDA Minor Species
Do you know the definition of an FDA Minor Species? Take the test: a. Animals under 2 ft tall b. Animals that cannot drive or drink c. Animals that dig for gold or silver d. Animals that sing off-key e. Animals…
Latest Posts
FDA to collect information on financial disclosure requirements for clinical investigators
FDA is currently seeking public comments regarding the recordkeeping burden of compliance with 21 CFR 54. Investigators and research sponsors both have specific obligations under this section of the FDA regulations, which applies to any clinical investigation submitted to FDA…
FDA to host Pediatric Medical Devices Workshop
FDA’s Office of Orphan Products Development recently announced a public educational workshop to be held September 24, 2012 in Silver Spring, MD. The workshop, which will feature FDA and non-FDA-affiliated presenters, will focus on issues related to the development of…
House subcommittee votes to cut DHHS budget, defund AHRQ
The US Department of Health and Human Services budget would be cut by $1.3B, and funding for the Agency for Healthcare Research and Quality would be totally eliminated by a bill that passed the congressional Labor, Health and Human Services…
WHO releases proposed guidelines for research involving H5N1
The World Health Organization (WHO), issued a “Guidance for adoption of appropriate risk control measures to conduct safe research on H5N1 transmission”, available here. The proposed considerations are: 1. Facilities wishing to work with the laboratory-modified H5N1 should critically evaluate…
First Gene Therapy treatment approved in Europe
On 19 July 2012, after a second evaluation which involved the adoption of a formal opinion of the Agency’s Committee for Advanced Therapies (CAT), the Committee for Medicinal Products for Human Use (CHMP) concluded that Glybera’s benefits outweigh its risks…
System for award managment – SAM – coming online soon
CCR (the Central Contractor Registration) will transition to SAM at the end of July. CCR must stop accepting new data in order to successfully migrate the existing data into SAM. CCR’s last business day is Tuesday, July 24, 2012. It…
DATA Act – Update in the US Senate
The US Senate Committee on Homeland Security and Governmental Affairs held a hearing on July 18th: Show Me the Money: Improving the Transparency of Federal Spending. The purpose of this hearing was to hear from Sen. Mark Warner (D-VA; lead…
Report provides recomendations on NBAF (National Bio- and Agro-Defense Facility)
The Committee on an Analysis of the Requirements and Alternatives for Foreign Animal and Zoonotic Disease Research and Diagnostic Laboratory Capabilities; Board on Agriculture and Natural Resources; Board on Life Sciences; Division on Earth and Life Studies; National Research Council…
Tenth Meeting Set for Presidential Bioethics Commission
The next meeting of the Presidential Commission for the Study of Bioethical Issues will be held August 1-2, 2012, in Washington, DC. The discussion will focus on ethical issues related to pediatric research and human genome sequencing. For more information,…