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    RAPS Welcomes Germany Chapter

    RAPS added another European chapter as it announced the launch of the RAPS Germany Chapter . The group began its affiliation with RAPS as a local networking group before becoming an official chapter. The addition of the Germany chapter to RAPS’ global network brings the worldwide total to 19 chapters and eight local networking groups. “In Germany as elsewhere in Europe, RAPS’ presence has been enthusiastically received, linking local regulatory professionals with their...
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    A Record-High 362 Regulatory Professionals Pass the RAC Exam

    A record-high 362 regulatory professionals have passed the Regulatory Affairs Certification (RAC) exam during the most recent RAC exam period, RAPS announced today. Passing the RAC exam requires essential knowledge of healthcare product regulations, critical thinking and analytical skills. The rigorous exam challenges regulatory professionals not only to know applicable regulations, but also how they apply in various real-world situations. The 362 individuals who p...
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    RAPS 2020 Board Begins Term, Welcomes Trautman, Pokrop and Hoekstra

    The RAPS board of directors of officially began its 2020 term on 1 January. Don Boyer, a former top Health Canada official who is now a private regulatory consultant, is serving his second year as chairman. Boyer’s term was extended from one to two years when the RAPS board officers’ structure was changed by member vote in November. The term of the board president was also increased to two years, and the president-elect position was eliminated. “I am honored to have the...
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    RAPS Welcomes Colorado Chapter

    RAPS has announced the official launch of the RAPS Colorado Chapter . The group first began as a RAPS-affiliated local networking group before becoming a full chapter. Chapter leaders and other representatives attended RAPS’ recent Regulatory Convergence in Philadelphia, where they were welcomed and acknowledged by RAPS Executive Director Paul Brooks. “We are so pleased to officially welcome the RAPS Colorado Chapter,” said Brooks. “RAPS chapters are a vital part of ou...
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    RAPS Honors Four New Fellows

    RAPS today honored the 2019 class of RAPS Fellows , a distinction bestowed upon seasoned regulatory leaders who have gone above and beyond to give back to the profession and share their experience and expertise with others.   “To be named a RAPS Fellow, an awardee must exhibit unique dedication to the regulatory field that is demonstrated by a history of commitment and success,” said RAPS Chairman Don Boyer, BSc, RAC, FRAP. “From a strategic leader to a dedicated ment...
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    RAPS Honors Winners of Founder’s Award, Community Leadership Award and New Patient-Centered Health Award

    RAPS today recognized five distinguished individuals and one leading advocacy organization for contributions to the regulatory profession and to promoting public health.   “The Founder’s Award is RAPS’ highest honor,” said RAPS Executive Director Paul Brooks. “It recognizes exemplary professionals who have had a substantial and sustained impact over the course of their careers, shaping regulatory policy and practice, and advancing the regulatory profession.”   The ...
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    214 Earn Regulatory Affairs Certification (RAC), Including First Group to Earn Medical-Device- or Drugs-Specific RACs

    RAPS announced today that 214 individuals earned Regulatory Affairs Certification (RAC) during the most recent RAC exam period, this past spring. Of that group, 59 passed one of two new variations of the RAC exam designed to test knowledge of regulations pertaining to either pharmaceuticals or medical devices, specifically.   The RAC exams cover knowledge of healthcare product regulations, critical thinking and analytical skills that regulatory professionals with thr...
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    Gottlieb: Immediate Release Opioids to be Subject to REMS

    FDA Commissioner Scott Gottlieb on Thursday said that immediate-release (IR) opioids will be subject to the same risk evaluation and mitigation strategy (REMS) as extended-release and long-acting (ER/LA) opioids. The agency first required a REMS for ER/LA opioids in 2012. "This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements,...
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    European Commission and EMA Offer Guidance on Brexit for Pharma Companies

    As marketing authorisation holders (MAHs) based in the UK begin to form plans to transfer their marketing authorizations (MAs) to holders established in the EU, Norway, Iceland and Liechtenstein, the European Medicines Agency (EMA) and European Commission on Wednesday released guidance to prepare industry for the UK’s withdrawal from the EU. The question and answer document is the first in a series of guidances and follows a notice sent earlier this month to ...
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    FDA Proposes to Withdraw Two Generic Versions of ADHD Drug Concerta

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday proposed withdrawing two generic versions of Janssen’s extended-release attention deficit hyperactive disorder (ADHD) drug Concerta (methylphenidate hydrochloride) two years after determining that they do not provide sufficient therapeutic effects. The manufacturers of the two Concerta generics - Kremers Urban Pharmaceuticals, a subsidiary of the Lannett Company, and Ma...
  • Facing Criticism, FDA Rethinking Some Therapeutic Equivalence Standards

    US regulators are taking a second look at the way generic drug applications for extended-release generic drug obtain approval several weeks after finding that Teva Pharmaceuticals and Impax Laboratories' Budeprion XL 300mg, supposedly generic to GlaxoSmithKlines' Wellbutrin 300mg, was in fact not therapeutically equivalent. The finding was a setback for the US Food and Drug Administration (FDA), which has fastidiously maintained that nearly all drugs approved through i...
  • EMA Releases Draft Guidelines on Oral Modified Release Products and Transdermal Patches

    The European Medicines Agency (EMA) has released two new draft guidelines on, respectively, the quality of oral modified release products and transdermal patches. The two draft guidance documents replace an earlier Note for Guidance on both topics released in July 1999.  Oral Modified Release Products The first guideline, Draft guideline on quality of oral modified release products , describes how Marketing Authorization Applications (MAAs) should address ...