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  • Regulatory NewsRegulatory News

    BIO Highlights IP Challenges Around the Globe

    As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products. "These challenges hinder or prevent innovators from securing patents (patent backlogs and restrictive patentabil...
  • Regulatory NewsRegulatory News

    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...
  • After 13 Years, FDA Finalizes Pediatric Trials Protection Rule

    A new final regulation just released by the US Food and Drug Administration (FDA) amends an existing regulation to include minor additional safeguards for pediatric patients, including children, enrolled in clinical trials. The long-anticipated rule has been in the works since 2001 , when FDA released an interim rule meant to comply with the Children's Health Act of 2000, which mandates that all pediatric research in the US offer subject additional protections to ensu...
  • DHHS Plans to Assess Need for Revisions to Human Research Protections at Upcoming Meeting

    • 21 September 2012
    The US Department of Health and Human Services (DHHS) is planning to meet in October to discuss whether current protections afforded to human research subjects are adequate, or whether new regulations and guidelines are needed. The meeting, announced in the Federal Register on 20 September , will involve DHHS' Secretary's Advisory Committee on Human Research Protections ( SACHRP ). The group, which acts as an advisory committee, is charged with providing recommendatio...
  • Human Protections Oversight Body Seeks New Members

    • 06 September 2012
    Officials at the US Department of Health and Human Services (DHHS) are looking for two new members to serve on the Secretary's Advisory Committee on Human Research Protections (SACHRP), the agency announced in a Federal Register posting . SACHRP is a part of DHHS's Office of Human Research Protections, which, along with the US Food and Drug Administration (FDA), is responsible for overseeing the rights and welfare of participants enrolled in clinical trials conducte...