• Regulatory NewsRegulatory News

    Biosimilar User Fees: Public Meeting Kicks Off Negotiations for BsUFA II

    The US Food and Drug Administration (FDA) began negotiations on the second biosimilar user fee program on Friday with a public meeting highlighting some of the roadblocks the agency has seen so far and what remains to be done to help make the US biosimilar market more robust. The current legislative authority for the Biosimilar User Fee Act (BsUFA) expires in September 2017, so FDA has to work with a number of stakeholders (industry, patients, academia, etc.) to devise ...
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    CDER’s Woodcock Outlines Priorities for 2016

    With a banner year for new drug approvals under its belt in 2015 (42 approvals and counting), the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is now looking at how it can not only negotiate three new user fee agreements but fill an enormous number of staff vacancies. CDER Director Janet Woodcock, speaking Monday at the FDA/CMS Summit in Washington, DC, outlined 2015’s achievements and a number of the agency’s top priorities for ...
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    Industry Conflicts With FDA: The Options

    Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month. The conversation on disputes came as FDA in September further clarified and updated its guidance on how it resolves complicated medical and scientific disagreements between industry and FDA. Informal D...
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    What Causes Variations in Review at CDER? It's All About the Designation

    Last year, a study by the Manhattan Institute for Policy Research (MIPR) found variations in review time at the US Food and Drug Administration's (FDA) various drug review divisions were caused by inefficiencies at the agency. Now, FDA representatives are making the case that the variation in review times can be explained by the proportion of applications receiving accelerated review in different therapeutic areas. The MIPR study concluded that the variations in rev...
  • Feature ArticlesFeature Articles

    What Influences CDER Advisory Committee Members?

    Over the past two decades, the US Food and Drug Administration’s (FDA’s) Center for Drug and Evaluation and Research (CDER) has been developing new, expedited pathways to help bring innovative medical products to market more efficiently. These pathways include fast track designation, accelerated approval, priority review and, more recently, breakthrough therapy. Through these expedited pathways, some products have been approved with fewer clinical data than traditio...
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    FDA Wants Public Input on How to Improve Drug Safety

    If you have an idea for what the US Food and Drug Administration's (FDA) pharmaceutical regulators should be working on, now is the time to speak up. In a Federal Register announcement on 19 March 2015, FDA said it "hopes to foster collaborations with external partners and stakeholders" to help address a long list of regulatory "needs and priorities" identified by its Center for Drug Evaluation and Research (CDER), which is in charge of regulating drug products. The...
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    After Months of Silence, FDA Returns to 'Name and Shame' Strategy on Pediatric Trial Compliance

    In 2013, the US Food and Drug Administration (FDA) launched a new webpage seemingly intended to shame companies into meeting their pediatric study commitments under the  Pediatric Research Equity Act ( PREA ). But after an initial deluge of postings, FDA's updates to the page have all but halted, with just five letters posted to the page after its launch, and none within the last six months. Now FDA has posted its first letter to the page in more than half a year detail...
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    FDA to Spend $1 Million to Develop Mathematic Model of Drug Sameness and Similarity

    Drug regulators with the US Food and Drug Administration (FDA) are pursuing the development of new technologies to better understand generic—and perhaps even biosimilar—drugs. In a 19 May 2014 funding announcement posted on the National Institute of Health's website, FDA explained that it's seeking help in developing a mathematical algorithm or model it can use to integrate various information to better understand which data can demonstrate "similarity or sameness of t...
  • CDER Launches New Training Tool For International Regulatory Bodies

    The US Food and Drug Administration (FDA) released a new training tool to the public on 24 February for  international regulators to "learn first-hand how [the Center for Drug Evaluation and Research (CDER)] organizes the drug review process and carries out its mission of ensuring the safety and efficacy of human drug products in the US." The tool, CDER World , acts as an Internet-based "compendium of information" about how CDER operates as an agency, adapts to t...