The FDA issued its expected guidance on rare disease drug development in late August, 2015, and public responses are due in October. Behind the scenes is the buzz of collaboration between patient advocacy groups and drug developers as we analyze, exchange thoughts, and prepare our responses to this important document. (Geeks Talk Clinical)
“…Fortunately, in November 2009, while working at the White House Office of management and Budget, I was able to convene representatives of HHS and other departments to develop reforms to enhance participant protections and make the oversight process more efficient. Those meetings led to an Advance Notice of Proposed Rulemaking in 2011 and release of a Notice of Proposed Rulemaking (NRPM) this September. The end of this process is now in sight.” (The New England Journal of Medicine)
As the Food and Drug Administration (FDA) transitions between commissioners, continues negotiating industry user fee commitments and prepares for a possible legislative overhaul, a major transformation is in the works for the agency over the next couple of years. (RAPS, Regulatory Focus).
Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products & tobacco, Robert Califf. (Applied Clinical Trials)
Human Longevity (HLI), the genomics-based, technology-driven company, has announced that Sally Howard, J.D., has been hired as head of regulatory affairs and policy. Howard, who has more than two decades of health policy and regulatory expertise, will lead all efforts related to federal and state regulatory oversight for HLI. (CenterWatch News Online)
The U.S. National Institutes of Health (NIH) will start enrolling 1 million or more U.S. citizens as the first key step to implementing President Obama’s nationwide Precision Medicine Initiative (PMI). Plans for the clinical research cohort were outlined in September by the NIH Advisory committee. ($. Nature Biotechnology)
FDA Docket. Using technologies and innovative methods to conduct Food and Drug Administration-. Oct 2015
Using Technologies and Innovative Methods to Conduct Food and Drug Administration – Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket. Food and Drug Administration, Health and Human Services. October 29, 2015
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit input from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations.
The U.S. Food and Drug Administration (FDA) on Wednesday announced it’s looking for more information on technologies and innovative ways to more efficiently conduct clinical research. The use of smartphones and tablet devices to collect trial participant data seems to be of particular interest to FDA as it’s requesting more information on the challenges associated with collecting data on trial participants’ own devices, which FDA says may be used to access and respond to study-related questionnaires. (Zachary Brennan, Regulatory Focus)
Product Development Under the Animal Rule. October 27, 2015. Final. CDER