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  • Regulatory NewsRegulatory News

    CDER Goals for 2017: Improved Informatics, Cures Act Implementation and User Fees

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock outlined the critical priorities for 2017 in a new podcast as part of what she said will be "another busy and productive year." On the informatics front, Woodcock said that last summer, the executive committee of the FDA had a retreat and "the number one item there was improving and really implementing Informatics Process Management and so forth across the w...
  • Regulatory NewsRegulatory News

    'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017

    The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday at the FDA/CMS Summit in Washington, DC, that she's looking to develop a plan to automate processes for new drug reviews, implement provisions of the 21st Century Cures Act and support the reauthorization of the user fee acts in 2017. 21st Century Cures On Tuesday, President Obama signed the 21st Century Cures Act into law, ushering forth...
  • Regulatory NewsRegulatory News

    GDUFA Science Priorities for 2017: Postmarket Evaluation and Complex Generics

    In the final year of the first Generic Drug User Fee Act (GDUFA I), FDA’s Office of Generic Drugs (OGD) is planning to prioritize the post-market evaluation of generics, work on the equivalence of complex generics and locally acting products, as well as new standards and computational and analytical tools. The release of OGD’s regulatory science priorities on Thursday comes as 2016 saw a banner year for generic approvals, with 651 approvals (or 835 if tentative approv...
  • Regulatory NewsRegulatory News

    CDRH Outlines Top 10 Science Priorities for 2017

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) plans to leverage real-world evidence and more “Big Data” for regulatory decisions, according to a list of its science priorities for 2017. As far as what will change between 2016 and 2017, the 13-page report says that thanks to more “needs submissions from staff,” CDRH was able to identify new topic areas, including clinical trial design and precision medicine, as well as desc...
  • Regulatory NewsRegulatory News

    FDA Looks to Fine-Tune the Balance Between Premarket Device Data and Postmarket Requirements

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday announced that it has completed its target goal under its 2014-2015 strategic priority on striking the right balance between premarket and postmarket data. The goal for CDRH was to review 100% of the medical devices subject to a premarket approval applications (PMAs) approved prior to 2010 to determine, for each product code, whether or not to reduce premarket data co...
  • Regulatory NewsRegulatory News

    CDRH Sees Customer Satisfaction as a Driver of Innovation, Good Regulation

    The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory branch, has a question for industry: How have we helped you lately? Background It's a bit of an odd question without context. In February 2014, CDRH launched a new document, CDRH 2014-2015 Strategic Priorities , in which it said the device center would be focusing on three things in 2014: strengthening clinical trials, balancing pre- and post-mark...
  • India Announces Regulatory Priorities

    Clinical trial related issues account for four of the seven regulatory priorities announced by India's Central Drugs Standard Control Organization (CDSCO), the country's drug regulatory authority, on 10 April 2013.  According to the CDSCO notice, the priorities are regulatory issues that require "greater attention … for safeguarding and enhancing the public health."  Among the clinical trial-related priorities mentioned in the notice are the registrat...
  • Brazil's Anvisa Addressing Drug Approval Priorities

    Brazil's national regulatory authority, Anvisa, announced on 4 October a number of steps it has implemented to address the priority public health needs of the country, part of a multi-year reorganization aimed at better addressing the health and economic development needs of the country and its population. One of the measures it has implemented is the establishment of an expedited review and approval procedure for medicines deemed to be priority treatments for use by t...
  • Brazil: ANVISA Publishes 2012 Regulatory Priorities

    The 2012 Regulatory Agenda of the National Agency of Sanitary Surveillance (ANVISA) was published on 12 April in the Official Gazette (DOU) and includes the expansion of the national product surveillance system (Vigipós), as well as the publication of health guidelines for the transport of human biological material.  The priorities are grouped according to the agency's scope of regulatory authority: food, health administrative control, cosmetics, analytical...
  • CDRH Releases 2012 Strategic Priorities, Looks to Boost Innovation With New Regulatory Pathway and Regulatory Science

    The US Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) released their strategic priorities for the coming year on 24 January 2012.  The priorities consist of four main strategies and corresponding implementation goals, and includes several new and important initiatives. CDRH's first strategy is to "fully implement a total product life cycle approach to product regulation that takes "into consideration all of the relevant infor...