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  • Regulatory NewsRegulatory News

    Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development

    Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug Administration's (FDA) White Oak campus on Monday said. Biomarkers are biological characteristics that can be measured to give an indication of a biological process or the presence or likelihood of a disease.  They can also predict how a patient might respond to a particular inter...
  • Regulatory NewsRegulatory News

    Breaking Bottlenecks: FDA Clarifies Tool for Expediting Drug Development (Corrected)

    The US Food and Drug Administration (FDA) is trying to clarify how industry can request a meeting of the agency's Critical Path Initiative (CPI), a decade-old effort to accelerate drug development through the use of common standards. Correction: A previous iteration of this article suggested that FDA's effort under the Critical Path Initiative, as well as its Critical Path Innovation Meetings (CPIM), were connected with the Critical Path Institute (C-Path)—a public-priv...
  • Regulators, Industry Prepare to Dig into Liver Toxicity Concerns in Bid to Improve Safety

    A meeting proposed by US regulators would again seek to bring together the US Food and Drug Administration (FDA), pharmaceutical trade industry group PhRMA, the regulatory science-focused Critical Path Institute and public stakeholders to discuss best practices for detecting and assessing the likelihood that pharmaceutical products cause liver damage in patients. Background Liver toxicity, sometimes referred to as hepatotoxicity, is a serious but relatively c...
  • C-Path Obtains EMA, FDA Approval for Tool to Expedite Development of Alzheimer's Treatments

    The Critical Path Institute (C-Path), a public-private hybrid organization supported directly by the US Food and Drug Administration (FDA), has announced a "big step forward for Alzheimer's disease therapy development," saying that it has obtained the support of FDA and the European Medicines Agency (EMA) to launch a new disease simulation tool intended to improve clinical trial design for investigating Alzheimer's treatments. C-Path, which was founded in 2005 under FDA'...
  • Groups, FDA Announce Launch of New Clinical Data Standards Harmonization Partnership

    The US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) have announced the formal launch of a new clinical data standards consortium known as the Coalition for Accelerating Standards and Therapies (C-FAST). Both CDISC and C-Path are data organizations which set many of the global standards used to report data from clinical trials. The partnership between all three organizations w...
  • Consortium Brings Together FDA, Industry to Release New Data Reporting Standard

    Officials with the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path), two organizations strongly affiliated with the US Food and Drug Administration (FDA), have announced the release of a new "breakthrough tool" used to help combine and report data from multiple studies. The new tool is set to be used to standardize the way companies report data from research on drug regimens intended to treat tuberculosis (TB), a bacterial...
  • New Regulatory Data Standards Partnership Formed to Accelerate Research

    A new partnership between two regulatory organizations supported by the US Food and Drug Administration (FDA) has the potential to accelerate clinical research and medical product development, the groups said in a statement. In a 21 June statement, the Clinical Data Interchange Standards Consortium (CDISC) and the Critical path Institute (C-Path), announced the formation of a partnership with FDA to develop new data standards, tools and methods to guide the development o...
  • FDA Releases New Guidance for Clinical Evaluation of Irritable Bowel Syndrome Drugs

    The US Food and Drug Administration (FDA) has released final guidance for industry to assist sponsors looking to develop drugs to treat patients suffering from irritable bowel syndrome (IBS). The 30 May guidance, Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment , covers general IBS symptoms and addresses two sub-sets of IBS which primarily result in diarrhea (IBS-D) and constipation (IBS-C), which FDA said have unique consi...
  • C-Path Initiative's Work on Personalized Medicine Starts to Get Results

    The Critical path Institute (C-Path), the US Food and Drug Administration (FDA)-supported public-private initiative working to advance personalized medicine, is advancing quickly and is bearing results, reports The Arizona Star . C-Path, now under the leadership of President and CEO Dr. Carolyn Compton, is working with numerous private companies to create technologies to develop safer, more effective drugs. "The idea here is, through the creation of new tools, new meas...