• Regulatory NewsRegulatory News

    PhRMA, AdvaMed weigh in on safety reporting draft guidance

    Two industry trade associations and a pharmaceutical company are asking for some adjustments and clarification on the US Food and Drug Administration’s (FDA’s) draft guidance on safety reporting or investigational drugs and devices. The comment period on the guidance closed at the end of November.   FDA’s draft guidance includes details of how the agency believes investigators should report serious and non-serious adverse events in investigational new drug applicatio...
  • Regulatory NewsRegulatory News

    Key regulators featured in RAPS Convergence 2021 health authority forums

    On Monday, RAPS Convergence 2021 attendees will have the opportunity to hear from global regulators during three health authority forums. The presentations will highlight key topics and updates relevant to each regulatory body in hour-long sessions.   The session featuring Japan’s Pharmaceutical and Medical Devices Agency (PMDA) features four Japanese regulators, including session leader Tetsuya Kusakabe, PMDA’s international coordination officer, and Kanako Sasaki, de...
  • Regulatory NewsRegulatory News

    FDA Releases Guidance for Clinical Trial Sponsor-Investigators

    New guidance issued by the US Food and Drug Administration (FDA) instructs clinical trial sponsor-investigators on how to complete an investigational new drug application (IND)—an application used by FDA to approve the start of a new trial. As FDA notes at the outset of the new draft guidance document, Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators , "Sponsor-investigators seeking to do clinical research often do not have the reg...
  • Data Show Varied Use, Success of FDA's Expanded Access Program

    In recent years, much attention has been focused on the pharmaceutical industry and its use-and non-use-of the US Food and Drug Administration's (FDA) expanded access program. But how much success has it had? Background That program, sometimes referred to as the "compassionate use" program, allows patients to access experimental treatments they might otherwise not be eligible to receive. For a full explanation of the program, please see our Regulatory Explainer on ...