• 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

    CBER Strategic Plan 2017-2019: Increase Threat Preparedness, Improve International Collaborations

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released an interim strategic plan for FY 2017 through 2019, offering the same six overarching goals the center initially developed in 2011, though with updated strategies to achieve them. The center’s “inherently interrelated” five overarching program goals and final cross-cutting goal include: Goal 1: Increase the nation's preparedness to address threats as a res...
  • 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

    What Happens When Drug and Device Labeling Regulations Meet National Security Concerns?

    There exists in the US a stockpile of healthcare products that, one hopes, will rarely need to be used. Known as the Strategic National Stockpile (SNS), the stockpile contains drugs and medical devices intended to be helpful in the case of a national emergency, such as an outbreak of disease, a terror attack, natural disaster or other unforeseen events. Background: The SNS Technically the “stockpile” is not a single store of products, but rather a collection of strat...
  • Regulatory NewsRegulatory News

    FDA Quietly Announces Creation of New Regulatory Division, Search Begins for Leader

    The US Food and Drug Administration (FDA) is looking to hire a high-level regulatory official to lead the agency's brand new division of Regulatory Affairs Strategic Management (RASM), it announced this week. The position, for a deputy associate commissioner, was recently created "to respond to significant changes in the regulated industry" and FDA's scope of authority, the agency said in its job posting for the position. Explained FDA: "These changes includ...
  • 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...
  • CDER Unveils Five-Year Plan Focused on Smart Regulation, Scientific Innovation and Lean Management

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has released its strategic regulatory plan for the upcoming five-year period, reflecting a refined vision and new realities it says it will need to face in order to advance the regulation of pharmaceutical and biological products. FDA and its regulatory centers for drugs, devices and biologics regulatory put out targeted plans meant to guide the agency and its component centers ove...
  • 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...
  • FDA Seeks Industry Input on Regulatory 'Strategic Plan' to Fight Drug Shortages

    It's been more than a year since the US Food and Drug Administration (FDA) started to make a concerted, large-scale and coordinated effort to combat mounting drug shortages. But now, in response to new statutory requirements contained within the FDA Safety and Innovation Act (FDASIA) , the agency is reaching out to the public in the hopes of learning what more it might be able to do. Background The US has been grappling with a series of mounting drug shortages for the ...