A new draft guidance published by the US Food and Drug Administration (FDA) aims to clarify the responsibilities of institutional review boards (IRBs) in the oversight of investigators, research sites and investigational authority of sponsors. The draft guidance, IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed , aims to clarify the roles of IRBs, which are charged ...

A so-called "compassionate use" program launched by the US Food and Drug Administration (FDA) is helping increasing numbers of patients access potentially life-saving drugs at early stages in their development process, reports the Wall Street Journal . The compassionate use program is relatively straightforward: FDA allows manufacturers to provide some patients-generally only those with highly advanced and likely fatal diseases-with drug compounds still under early-...

The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of its time and resources to investigating several programs run by the US Food and Drug Administration (FDA) during 2013. OIG's plans were revealed on 2 October in the release of its Fiscal Year 2013 Work Plan , a 123-page document detailing the basic outline of its investigati...

A proposed piece of legislation would allow terminally ill patients to access drugs and medical devices that have not yet received approval from the US Food and Drug Administration (FDA). The bill, the Compassionate Freedom of Choice Act (CFCA) of 2012 , was introduced in the US House of Representatives on 2 August by Rep. Ron Paul (R-TX). In a statement on the House floor, Paul said the bill would address the needs of patients suffering greatly from an advanced ...

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) announced 28 February that it intends to conduct a pilot evaluation program for a new electronic data standard format to support application reviews. The new standard, developed by the Clinical Data Interchange Standards Consortium (CDISC), is known as the Standard for Exchange of Nonclinical Data (SEND). "FDA believes the use of standardized SEND datasets, together with ne...