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  • RAPS' LatestRAPS' Latest

    John Lim, Justina Molzon, Barbara Schneeman and Mike Ward to Receive RAPS’ Highest Honor

    RAPS has announced the recipients of its 2018 Founder’s Award. They are: John Lim, MD, executive director, Center of Regulatory Excellence, Singapore; Justina Molzon, JD, former associate center director for international programs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA); Barbara Schneeman, PhD, former director, Office of Nutrition, Labeling and Dietary Supplements, FDA; and Mike Ward, coordinator, Regulatory System Strengthen...
  • RAPS' LatestRAPS' Latest

    RAPS to Honor Lena Cordie, Alan McEmber for Outstanding Community Leadership

    RAPS has announced the recipients of its 2018 Community Leadership Award. They are: Lena Cordie, president, Qualitas Professional Services, and Alan McEmber, MS, RAC, head, therapeutic area regulatory strategy, Shire. The Community Leadership Award recognizes RAPS members who have helped build thriving local networks, supported fellow regulatory professionals and acted as RAPS ambassadors. Cordie and McEmber will be honored and receive their awards next week during RAP...
  • Regulatory NewsRegulatory News

    E-Submissions of REMS Documents: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Friday released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications. The agency said the implementation will begin no earlier than 24 months after issuance of the final guidance. The 7-page dr...
  • RAPS' LatestRAPS' Latest

    RAPS Honors Regulatory Leaders With Two New Awards

    RAPS will honor two groups of exemplary regulatory leaders next month at its annual Regulatory Convergence conference, being held at the Gaylord National Resort and Convention Center at National Harbor on the Washington, DC, waterfront 9–12 September . Four outstanding individuals who have had a profound impact on the regulatory profession during their careers will be the inaugural recipients of the Founder’s Award, the profession’s highest honor. Three honorees...
  • RAPS' LatestRAPS' Latest

    Remembering RAPS Founder Richard Greco

    RAPS Founder Richard E. Greco died last week near his home outside of Buffalo, NY. He was 87 years old. During his career, he served as vice president for regulatory affairs with Life Technologies and president of Regulatory Associates Inc. He has been honored by the US Food and Drug Administration (FDA) with the Commissioner’s Special Citation, and in 1979, he become the inaugural honoree of the eponymous Richard E. Greco Award from RAPS. Greco founded RAPS in 1...
  • Regulatory NewsRegulatory News

    Pazdur to Head New Oncology Center at FDA

    Vice President Joseph Biden on Wednesday named the US Food and Drug Administration's (FDA) top oncologist, Dr. Richard Pazdur, to head the newly formed Oncology Center of Excellence (OCE). The OCE is intended to accelerate the development of new oncology products, as part of Biden's $1 billion dollar cancer "Moonshot" initiative, by working with FDA's other centers for drugs, biologics and medical devices to promote a "cross-center" approach to reviewing oncology product...
  • Regulatory NewsRegulatory News

    Health Canada Finalizes IVD Labeling Guidance After 18 Years

    The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998. The final guidance includes new considerations for electronic labeling, IVDs with small containers, blood glucose monitors and information on complying with Canada's Official Languages Act , which requires product labels to be written in both French and English. Additionally, the guidance...
  • Regulatory NewsRegulatory News

    Additional Funding to Combat Zika Denied in House Markup of FDA Spending Bill

    The House Appropriations Committee on Tuesday marked up the FY 2017 spending bill for the US Food and Drug Administration (FDA) and decided not to include an amendment adding $1.9 billion in additional funding requested by President Barack Obama to combat the Zika virus. Republicans argued that Obama did not provide enough specifics on where the funds will go and they voted against Rep. Nita Lowey’s (D-NY) amendment that would have attached the Administration’s additiona...
  • Regulatory NewsRegulatory News

    FDA Shares Views on Juvenile Animal Studies for Oncology Drugs

    In a recently published article, officials from the US Food and Drug Administration (FDA) say that studies comparing the effects of drugs in juvenile animal populations against their effects in adult animals are generally not useful in guiding pediatric clinical development, especially if such studies delay the launch of a clinical trial. The authors of the article, John Leighton, Haleh Saber, Gregory Reaman and Richard Pazdur, of FDA's Office of Hematology and Oncology ...
  • Regulatory NewsRegulatory News

    Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement

    Editor's note: After publishing this article, Focus received comments from Bayer refuting the allegations made by Rep. Fitzpatrick. See our coverage of Bayer's comments in a follow up article published Thursday. Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the U...
  • Regulatory NewsRegulatory News

    New Bill Directs FDA to Pull Bayer Birth Control Device

    In an unprecedented move, Rep. Michael Fitzpatrick (R-PA) on Wednesday unveiled a new bill that directs the US Food and Drug Administration (FDA) to withdraw from the market Bayer’s birth control implant Essure. The safety of the implantable device, which is used for permanent birth control, has been called into question recently, with FDA holding an advisory panel meeting on the device's safety in September. Rep. Rosa DeLauro (D-CT) also requested FDA pull the produc...
  • FDA to Spend up to $10 Million Strengthening Regulation in South America

    • 17 July 2014
    US regulators are planning to work more closely with a global health group focused heavily on South America in the hopes of strengthening medical product regulatory systems across the region. In an announcement on 8 July 2013, the US Food and Drug Administration (FDA) said it plans to award the Pan American Health Organization (PAHO) a contract to help "foster regulatory collaboration and strengthen regulatory capacity throughout the Americas." Regulatory capacity broad...