• Regulatory NewsRegulatory News

    FDA gives generics updates at DIA town hall

    Officials at the US Food and Drug Administration (FDA) addressed plans to prioritize on-site inspections and gave updates regarding certain new drug applications during a generics-focused virtual town hall convened by the Drug Information Association (DIA) as part of its virtual annual meeting. During the session, regulators also shared post-pandemic learnings, including the importance of international collaborations for generic drug development.   The session inclu...
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    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
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    2018 in Generic Drugs: Approvals Shine but Questions Remain on Competition

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) this week released its year in review, highlighting another banner year for approvals and new guidance documents. 2018 was the first year of GDUFA II, during which FDA implemented certain new provisions tied to the program and the FDA Reauthorization Act of 2017 (FDARA), including pre-ANDA meetings, reconsideration requests, one-time marketing status updates to the Orange Book and competitive gen...
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    FDA Names New Office of Generic Drugs Director

    In an email to staff on Tuesday, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced that Sally Choe will take over for Kathleen Uhl as Director of the Office of Generic Drugs (OGD) upon Uhl’s retirement at the end of the month after serving more than 20 years at the agency.   “With more than 18 years of experience in global drug development, Sally is an accomplished leader in both governmen...
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    WHO Elects First African Director-General

    The World Health Organization (WHO) on Tuesday announced that Dr. Tedros Adhanom Ghebreyesus of Ethiopia has been elected by member states as the new Director-General of WHO. Nominated by the Ethiopian government, he will begin his five-year term on 1 July 2017 and succeed Dr. Margaret Chan, who has been Director-General since January 2007. Chan addressed the 70th World Health Assembly on Monday, noting the challenges that lay ahead for the agency. Ghebreye...
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    FY 2016 Generic Approvals by FDA: A New Record Under GDUFA

    The US Food and Drug Administration (FDA) published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014 . But that high approval figure for last year also comes as the agency sent more complete response letters (CRLs) than any other year....
  • RAPS' LatestRAPS' Latest

    RAPS Appoints Paul Brooks as Next Executive Director

    • 11 August 2016
    RAPS today announced that Paul Brooks has been appointed executive director. Brooks will officially join RAPS on 12 September 2016. He succeeds Sherry Keramidas, who retired last January after 20 years at RAPS. Brooks served on the RAPS board of directors from 2008 through 2013, and was chairman in 2013. He has been actively involved with RAPS as a volunteer representative and leader for two decades. “After a thorough search, the board of directors unanimously ...
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    Former FDA Deputy Director Charged With Insider Trading for Leaking Non-Public Approval Information

    A former Deputy Director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) was charged on Wednesday for providing tips on drug approvals to three hedge fund managers that made tens of millions off of the non-public information. The Securities and Exchange Commission (SEC) announced the charges of insider trading against two hedge fund managers and their source, Gordon Johnston, who worked for a dozen years at FDA and leaked approval in...
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    RAPS Releases Position Specification for New Executive Director

    RAPS has taken the next step in its search for a new executive director , releasing the position specification , which details the qualifications, responsibilities and competencies required of potential candidates. RAPS' board of directors and its executive director search committee worked with executive search firm Russell Reynolds Associates (RRA) to develop the specification. The full position specification document is available online or by contacting RRA...
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    Generic Drug Approvals Hit New Record in 2015, FDA Report Shows

    • 13 April 2016
    The US Food and Drug Administration (FDA) approved more generic drugs in 2015 than ever before and is on track to meet all of its goals from the Generic Drug User Fee Act of 2012 (GDUFA) by 2017, according to the first annual report from FDA’s Office of Generic Drugs (OGD). More than 700 generic drugs were approved and tentatively approved in 2015, which was the highest figure ever; and in December, FDA granted the highest number of approvals and tentative approvals in...
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    RAPS Launches Search for New Executive Director, Announces Interim Management Team

    • 18 February 2016
    The RAPS board of directors announced today that it has initiated a search for its next executive director and that it has selected Russell Reynolds Associates (RRA), a global leader in assessment, recruitment and succession planning, as its partner in identifying a new leader. RAPS, which is the world’s largest organization serving professionals involved in the regulation of medical products, this year celebrates its 40th anniversary in providing leading educatio...
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    RAPS Announces Retirement of Executive Director

    • 11 December 2015
    RAPS announced today the retirement of its Executive Director Sherry Keramidas whose leadership during a 20-year tenure helped advance the healthcare regulatory profession. She will retire on 31 January 2016. “Sherry has served RAPS and its members during a critical period of change in the healthcare industry,” according to RAPS Chairman of the Board Rainer Voelksen. “Her constancy throughout ensured RAPS’ mission to provide leading education and professional deve...