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  • 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

    OND Reorganization Moves Forward

    The US Food and Drug Administration said Thursday that the planned reorganization of its Office of New Drugs (OND) will move forward thanks to Congressional approval, including changes to its Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ). The changes will create offices for interrelated disease areas and divisions with clearer and more focused expertise, FDA said , noting the number of OND offices that oversee its review division...
  • Regulatory NewsRegulatory News

    As the Race for a Permanent FDA Commissioner Picks Up, Agency Turnover Continues

    With a decision on a permanent US Food and Drug Administration (FDA) Commissioner slated for the end of October at the latest, the steady stream of FDA employee defections to industry continues. So, who will be nominated as the next commissioner? Some influential health groups and former FDA commissioners (including Scott Gottlieb), according to the Washington Post , are pushing for Acting Commissioner Ned Sharpless to be nominated, while the Wall Street Journal...
  • Regulatory NewsRegulatory News

    FDA Updates COA Compendium for First Time Since 2016

    As part of the US Food and Drug Administration’s (FDA) efforts to encourage more patient-focused drug development, the agency on Wednesday released an updated Clinical Outcome Assessment (COA) Compendium as a resource on a variety of different diseases and conditions. The compendium, which has been updated for the first time as part of an extension to a pilot COA Compendium that was launched in January 2016, can help companies understand how certain COAs have been used ...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese OTC Drug Manufacturer for Falsifying Documents

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research earlier this month sent a warning letter to China-based sunscreen and OTC drug manufacturer NingBo Huize Commodity Co. after the company’s general manager and quality manager admitted that multiple documents provided to FDA were falsified “for the purpose of this inspection.” FDA placed the firm on import alert in June and said that the firm agreed to recall all drug products distributed...
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    CDER Plots Pilot Project to Test CDISC Standard

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday said it will conduct a small pilot project to test the processing and analysis of nonclinical study data provided electronically using an updated standard, known as the SEND 3.1, from the Clinical Data Interchange Standards Consortium (CDISC). CDER is seeking a maximum of five participants for the pilot, which will evaluate the compliance of sample SEND 3.1 datasets subm...
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    CDER Looks Ahead at Real World Evidence

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Friday held a webinar reviewing the agency’s real-world evidence (RWE) framework, which deals primarily in the postmarket space for drugs and biologics. The agency  unveiled  its RWE framework last December to provide a high-level view of how it is looking at the use of real-world data. Jacqueline Corrigan-Curay, director of the Office of Medical Policy within CDER, explaine...
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    CDER Guidance Agenda for 2019: What’s Coming

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue almost 100 new draft and revised draft guidance documents spanning 15 different categories, from biosimilars to clinical pharmacology to drug safety, in 2019. The bulk of the guidance documents are contained in three categories: clinical/medical, pharmaceutical quality/CMC and procedural. The guidance in clinical/medical focuses on specific types of develop...
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    FDA's Record Year: A Look at 2018 New Drug Approvals

    The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...
  • 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

    CDER Report on Novel Approvals Highlights Firsts in 2017

    2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties. And though the total 46 approvals is the second-highest number of approvals by CDER ever, according to the CDER ...
  • Regulatory NewsRegulatory News

    Woodcock: CDER Informatics System is Top Priority for 2018

    Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system. Woodcock made the comment at the FDA/CMS Summit in Washington, DC on Tuesday, noting that the rest of CDER's priorities for 2018 will be similar to priorities in 2017. Among those are implementing the 21st Century Cures Act ; working toward the goal...