• Regulatory NewsRegulatory News

    FDA’s CDER Unveils Plans for 2016 Guidance Documents

    The guidance agenda for the next fiscal year from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) reveals a lot of new advice on generics, pharmaceutical quality, off-label communications and other recommendations carried over from 2015, particularly on the implementation of the Drug Supply Chain Security Act (DSCSA). The 15 categories of guidance documents planned for 2016 range from advertising (including a potentially controv...
  • Regulatory NewsRegulatory News

    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 ...