• Regulatory NewsRegulatory News

    CDER Plans 90 Guidance Documents in 2015, Including on Biosimilarity and Social Media

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has released a new list of 90 guidance documents it plans to publish in 2015, including several long anticipated and eagerly awaited by members of the pharmaceutical industry. The list, Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015 , is published annually by FDA ( 2012 , 2013 , 2014 ), and is meant to outline FDA's regulat...
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    FDA Touts Strong Drug Approval Performance in 2014

    The US Food and Drug Administration (FDA) is touting the number of new molecular entities it has approved thus far in 2014, saying the numbers are indicative of a "strong year for novel drug approvals." A Strong Year for Approvals "With a few weeks left in December, our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel new drugs in 2014 compared to 27 in 2013," said FDA Commissioner Margaret Hamburg in a posting on the agency's FDA Voice blo...
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    What Will it Take to Build Global Regulatory Capacity?

    The closing plenary of 2014 RAPS: The Regulatory Convergence in Austin, TX, featured a lively panel discussion about the importance of building regulatory capacity around the world, and how regulatory and healthcare leaders can go about building that capacity. The sessions touched on complexity and opportunity in global healthcare, themes that were repeated throughout the conference, which took place 27 September—1 October 2014. Panelists were Martha Brumfield, PhD...
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    FDA’s Woodcock Talks About Advancing Innovation at 2014 RAPS

    During the first day of 2014 RAPS: The Regulatory Convergence on 29 September 2014, Janet Woodcock, director of the US Food and Drug Administration’s Center for Drug Evaluation and Research spoke to attendees via a pre-recorded video. Woodcock covered some important initiatives and changes in drug development and regulation and the importance of finding more efficient ways to present clinical evidence to help translate medical innovations into therapies more quickly. Sh...
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    2014 RAPS Keynote Examines Future of Healthcare in Complex World

    2014 RAPS: The Regulatory Convergence kicked off on 29 September 2014 in Austin, TX, featuring a keynote presentation from David Bosshart, PhD, CEO of the Switzerland-based think tank, the Gottlieb Duttweiler Institute. Bosshart discussed the challenges of making things as simple as possible in an increasingly complex global healthcare environment. Watch his presentation and the rest of the opening plenary here. The Regulatory Convergence is the largest annual gathering o...
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    Join RAPS or Renew at The Regulatory Convergence and Get a RAPS Jersey

    You may have seen RAPS’ latest membership campaign featuring images of a leather biker jacket, a flight jacket and a soccer jersey with “Regulatory Affairs Professionals Society” printed on each of them, and taglines matching the images. The tagline for the soccer jersey ad, for example is, “It’s a fast-paced job. Get the support of a team to meet your goals.” The biker jacket ad says, “It’s a tough job. This is your gang.” The response to the campaign has been very...
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    Reintroducing Regulatory Focus: A New Look With New Features

    If you haven't already noticed, Regulatory Focus has a brand new look. What may not be so obvious are some of the changes throughout the Focus website—changes that should make for a more enjoyable and interactive experience for readers. The first major change has to do with how the site works on devices. The site is now built using "responsive design" elements , which means that it will automatically scale to whatever window size or device you're viewing it on....
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    Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

    The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014. DQSA-Related Rules Several are related to FDA's new authority under the Drug Quality and Security Act (DQSA) of 2013, which contains numerous provisions intended to enhance FDA's ability to regulate compounding pharmacies. For example, FDA plans to issue pro...
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    RAPS Taiwan Chapter Becomes First in Asia

    RAPS has announced the establishment of a new chapter in Taiwan, its first in Asia. The RAPS Taiwan Chapter originated as an affiliate. In making the move to become an official chapter, it will be able to offer additional resources and opportunities to the regulatory community in Taiwan. "Regulatory professionals from Taiwan can look forward to local training and networking activities while continuing to access RAPS resources for their professional development and career...
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    RAPS Seeks Fellows Candidates

    RAPS is seeking applicants who want to make a difference in the regulatory profession as members of the 2014 Class of RAPS Fellows . The RAPS Fellows program recognizes experienced regulatory professionals for their continued significant contributions and leadership in the advancement of the profession. The deadline for applications is 6 June 2014 . Those selected as Fellows hold the FRAPS designation, and may receive exclusive invitations to participate in strategic d...
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    Embracing Change in EU Medical Device Regulation: The Notified Body Perspective

    The RAPS San Francisco Bay Area Chapter kicked off 2014 with a 7 March conference focused on the proposed EU medical device regulations. Topics covered both near-term and long-term changes in key requirements critical to demonstrating compliance to existing directives and impending changes as proposed. The message was clear-change is underway in the EU and the medical device industry needs to be ready sooner than anticipated. A BSI Healthcare medical device expert team p...
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    RAPS Award Winners Reflect on Importance of Regulatory Profession and Giving Back

    Each year, when the recipients of RAPS' prestigious annual awards for outstanding contributions to the regulatory profession take the stage at RAPS' annual Regulatory Convergence conference, they find themselves somewhere unfamiliar to most regulatory professionals-in the spotlight. Annually, RAPS bestows upon a select group of worthy honorees, several awards for exemplary professional leadership, volunteerism, mentoring and advancement of the regulatory profession, whi...