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    Qualification of Drug Development Tools: FDA Updates Process

    Thanks to the 21st Century Cures Act , there will be an updated, multi-stage process for qualifying Drug Development Tools (DDTs), which include biomarkers, animal models and clinical outcome assessments. The US Food and Drug Administration (FDA) on Thursday said its goal is to transition from the legacy process to the new one, outlined in section 507 of the law, through a phased approach and the agency is currently developing a transition plan for existing projec...
  • First-Ever Drug Development Tool Tentatively Clears FDA's Qualification Process

    Just days after releasing a guidance document extolling the virtues of its drug development tool (DDT) qualification process, the US Food and Drug Administration (FDA) has tentatively released the text of its first qualified clinical outcome assessment (COA) tool, one intended to expedite the development of products to treat chronic bronchitis. Background The DDT program, as explained in a final guidance released on 6 January 2013 , is intended to help guide the develo...
  • Eyeing Quicker Regulatory Approvals, Regulators Finalize Guidance on Drug Development Tools

    Mere months after releasing a development tools guidance intended for medical device manufacturers, the US Food and Drug Administration (FDA) is following its own lead by releasing an extensive final guidance for the pharmaceutical industry outlining the qualification process for developing and validating drug development tools. Background FDA has placed a strong focus on drug development tools (DDTs) in recent years. At its most basic, a DDT is intended to help guide...
  • FDA Creates Program to Boost Regulatory Science, Speed Drug Development

    The US Food and Drug Administration (FDA) is announcing the launch of a new program that it hopes will help to advance clinical trial design and endpoints to boost regulatory science and facilitate expedited drug development. The program, which FDA is calling the Drug Development Tools (DDTs) Qualification Program, is being run by FDA's Center for Drug Evaluation and Research (CDER). The Center sees the program as "a mechanism for formal review by CDER to qualify drug de...