• Regulatory NewsRegulatory News

    Pazdur, Marks and Woodcock Discuss FDA Changes, What’s Coming

    Three of the US Food and Drug Administration’s (FDA) directors – Richard Pazdur, Peter Marks and Janet Woodcock – took the stage Wednesday at Prevision Policy’s Biopharma Congress to discuss all things FDA – from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers. Center for Drug Evaluation and Research Director Woodcock said that the difference between years past, when FDA was viewed negatively, and now is tha...
  • Regulatory NewsRegulatory News

    FDA's Woodcock, Marks and Pazdur Talk Sustainability and New Approaches

    Three of the US Food and Drug Administration's (FDA) top experts sat together on a panel at the third Biopharma Congress in Washington, D.C. on Tuesday, discussing everything from where the agency is headed in the next several years, how the costly clinical trial system is not sustainable and how they interview prospective FDA employees. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), reiterated a claim she made back in September ...
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    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...
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    FDA’s Pazdur and Blumenthal: The March of Checkpoint Inhibitors Will Continue

    More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature . Those expectations follow 2016 oncology approvals for FDA that included five new molecular entities and 17 ef...
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    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...
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    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 ...
  • FDA Approves Orphan Drug Application for Pfizer CML Drug

    The US Food and Drug Administration (FDA) has approved Pfizer's new orphan drug application for Bosulif (bosutinib), a tyrosine kinase inhibitor used to treat chronic myelogenous leukemia (CML). CML is a bone marrow and blood disorder that affects more than 5,000 adults in the US each year, and is generally associated with patients with a chromosomal abnormality known as the Philadelphia chromosome. Patients with this chromosome over-produce abnormal white blood cells,...
  • Capping Busy Week, FDA Approves Breast Cancer, Multiple Myeloma Drugs

    The US Food and Drug Administration (FDA) approved two new drug entities for treating, respectively, certain forms of breast cancer and multiple myeloma on Friday, 20 July. The approvals capped off a busy week for the agency, marking the fourth approval and second new molecular entity in the five-day period. Afinitor (everolimus) , manufactured by Novartis Pharmaceuticals, was approved for the treatment of postmenopausal women with advanced formone-receptor positive, HE...
  • FDA Approves New Breast Cancer Drug Despite Manufacturing Concerns

    Genentech's application for Perjeta (pertuzumab ) won marketing approval from the US Food and Drug Administration (FDA) on 8 June, bringing to market a new-and expensive-biologic product for the treatment of advanced breast cancer. Perjeta is a humanized monoclonal antibody, and works in conjunction with Herceptin (trastizumab) to further reduce the growth of HER2-positive cancerous cells in breast cancer patients. The HER2 gene is associated with approximately 20...
  • FDA Anticipates Spike in Oncology Drugs, Reduction in Shortages

    Could 2012 be the year a long-running drought in product approvals and availability finally ends? The US Food and Drug Administration (FDA) is of the opinion that it might just be-if only for oncology products, at least. Reuters reports Dr. Richard Pazdur, FDA's head of the Office of Hematology Oncology Products within the Center for Drug Evaluation and Research (CDER), told attendees of the American Society of Clinical Oncology (ASCO) conference in Chicago he anticipa...
  • New FDA Guidance Could See Patients Obtaining Quicker Access to Experimental Therapies

    The US Food and Drug Administration's (FDA) newly released draft guidance on neoadjuvant breast cancer treatments has the potential to radically change the existing pathway through which patients with aggressive early-stage breast cancer can obtain treatment, say experts. The guidance, released on 28 May,  is "intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant setting using pathologic co...
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    Outstanding Contributions Deserve Outstanding Recognition

    Nominations are now open for RAPS awards, which go to regulatory professionals with diverse, global backgrounds. The RAPS Awards Committee is currently seeking nominations for RAPS' annual awards honoring outstanding regulatory professionals in the healthcare products sector. RAPS' awards programs provide an important opportunity to acknowledge outstanding individual contributors to the regulatory field. This year, the committee has made significant improvements to the...