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  • Regulatory NewsRegulatory News

    Nature Editorial: FDA Needs Help Assessing Cutting-Edge Tech

    • 07 August 2017
    The US Food and Drug Administration (FDA) is increasingly being tasked with evaluating cutting-edge therapies and technology that its in-house expertise may not be able to address, according to a Nature editorial, which recommends academic scientists help the agency. Using the example of the 12 July meeting of the Oncologic Drugs Advisory Committee that voted unanimously in favor of the benefit-risk profile for the first of a new kind of cancer therapy, the ed...
  • Regulatory NewsRegulatory News

    EU Proposes More Structured Convergence With FDA on Pharma Regulations

    The European Union has offered a new proposal that would further harmonize the pharmaceutical regulations between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which could speed new drug approvals and manufacturing inspections in both regions. The seven-page proposal, released ahead of Transatlantic Trade and Investment Partnership (TTIP) negotiations between the EU and the US, would create a specific annex in those trade talks o...
  • Regulatory NewsRegulatory News

    Evolving Partnership: EMA Looks to Expand Work With Academia

    The European Medicines Agency (EMA) is intent on establishing a firmer framework for its work with academia as the agency needs to keep abreast of advances in science and continue to hone its regulations. Currently, like in the US, academia provides the European drug regulatory system with thousands of experts to ensure new treatments are evaluated and monitored to the highest scientific standards. And as advances lead to new medicines developed, manufactured, assessed...
  • Regulatory NewsRegulatory News

    India’s CDSCO Offers Four New Updates to Promote Clinical Research

    India’s Central Drugs Standard Control Organization (CDSCO) issued four new circulars on Tuesday that all seek to help promote clinical research on the subcontinent. The new circulars come as pharmaceutical research in India has been on the decline in recent years. CDSCO approved 19 trials through the first four months of 2015, which compares with 76 trials approved through the first five months of 2014, and 24 approved over the same time in 2013. Academic Research ...