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  • Brazil: New Board Procedures Established For Oral Arguments

    Major changes to the way ANVISA Board meetings are run were published on 25 April ( Ordinance 616/2012). Companies in the regulated sector will now have two ways to comment during the open phase of the Board meeting: They may request the opportunity to present oral arguments concerning administrative appeals or ask for an opinion. Requests for oral argument must be submitted at least two days before the scheduled Board meeting and if the applicant wishes to have t...
  • Eli Lilly's Lechleiter Replaces Sanofi's Veibacher as PhRMA Chairman

    • 16 April 2012
    The Pharmaceutical Researchers and Manufactuers of America (PhRMA), the powerful trade organization of the pharmaceutical industry, announced at its annual meeting its members have elected John C. Lechleiter, CEO of Eli Lilly and Co., as its next chairman. Lechleiter will replace outgoing Chairman Christopher Veichbacher, CEO of Sanofi, who has served the organization since 2008. The Chairman of the PhRMA Board-along with PhRMA's President, currently John Castellani-has...
  • Texas Approves New Stem Cell Therapies, Setting up Possible FDA Showdown

    The state of Texas approved new-and controversial-rules to allow doctors to use adult stem cells to conduct institutional review board (IRB)-approved procedures on patients, reports The New York Times . The changes, instituted 13 April by the Texas Medical Board, were reportedly spearheaded by Texas Governor and former Republican presidential nominee Rick Perry, who has said he experienced relief from the procedures, reports The Times . Some researchers, however, are ...
  • Anvisa Reorganization Published

    • 09 April 2012
    The reorganization of Brazil's national agency, Anvisa, was officially unveiled in the Official Gazette and defines those responsible for the new organization. CEO Dirceu Barbano will head the Board of Health Authorisation and Registration. Director Jaime de Oliveira will coordinate the work of the Joint Coordination and the National Health Surveillance System. Director José Agenor Alvares da Silva will conditionally head up the Board of Sanitary Control and Mo...
  • EMA Tightens Conflict-of-Interest Policies

    The European Medicines Agency (EMA) announced it will, effective immediately, be tightening its conflict-on-interest policies for scientific experts and members of advisory committees. The policy was announced 3 April after being endorsed by EMA's Management Board on 22 March 2012. "The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research," explained EMA in a statement. "It aligns restrictions for the differ...
  • EMA Strengthens Conflict of Interest Policies

    The European Medicines Agency (EMA) announced Monday, 26 March its Management Board has endorsed a proposal from EMA Executive Director Guido Rasi to strengthen conflict of interest policies surrounding its scientific committee members and experts. The Management Board also adopted several other initiatives, including a transparency initiative to "increase the transparency of all pharmacovigilance activities of the Agency and national authorities" while implementing the ...
  • CDER Announces Medical Policy Board, Adverse Events Reporting App

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) announced Friday, 6 January, that it is creating a medical policy board and a smartphone application for adverse event reporting, according to BioCentury and FDA News , respectively. The medical policy board, first reported on Friday by BioCentury , would serve to standardize medical decision making by CDER reviewers in light of industry comments that reviewers are occasion...