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  • Regulatory NewsRegulatory News

    Pazdur: Oncology accelerated approvals under review by ODAC

    On 27 April, the US Food and Drug Administration’s Oncology Drugs Advisory Committee (ODAC) meets to consider the fate of a half-dozen oncology immunotherapy indications granted accelerated approval. The confirmatory trials of these drugs have not verified their clinical benefit in the indications for which they received approval.   The virtual meeting will take stock of the indications individually; committee members will engage in a “general discussion focused on nex...
  • Regulatory NewsRegulatory News

    Is FDA Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss

    From industry to academia, commenters have argued that the US Food and Drug Administration’s (FDA) drug approval standards are becoming inappropriately low and that the required postapproval evaluations are either inadequate or left undone. But three senior FDA officials offered several counterpoints on Monday at the fifth annual Biopharma Congress in Washington, DC. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained that the agency ...
  • 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

    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...