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  • Regulatory NewsRegulatory News

    Health Canada to Release Drug, Device Rejection Letters

    As drug and device manufacturers are still not obligated and often don’t fully explain why their products were rejected by the US Food and Drug Administration (FDA), Health Canada has moved ahead to release its rejection reports beginning 1 May. The move by Health Canada, which will apply to any decisions issued after 1 April 2015, will mean the release of all final negative decisions and withdrawals for all new drug submissions (NDSs), supplemental new drug submissions ...
  • BIO Head Calls for New Position to be Formed at FDA to Boost Innovation

    The head of the Biotechnology Industry Organization (BIO), the leading trade group for biotechnology and biopharmaceutical organizations in the US, called on the US Food and Drug Administration (FDA) to make room in its organizational structure for a Chief Innovation Office (CIO), reports The Boston Business Journal . Speaking at the organization's annual meeting in Boston, BIO President and CEO James Greenwood said FDA has a duty to go beyond its mission to protect con...