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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (20 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Risk-Based Approach to Biologic Licenses, Ending Mandatory Inspections The Drug Controller General of India (DCGI) has scrapped the need for manufacturers to undergo a joint inspection before receiving certain biologics licenses. Instead of conducting pre-approval visits, Indian regulators will award Form 29 licenses within three days of receiving applications ...
  • New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

    The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint , which charts the course for the future development of bioscience research in the US and addresses numerous regulatory issues. The blueprint is described as a priority of the administration because of the "tremendous potential for growth and job creation." While basic research is an important aspect of the bioeconomy, said OST, regulatory issues are key drivers of ...
  • House PDUFA Draft: Make FDA's Review Process Take Into Account Job Creation

    Draft legislation to reauthorize a number of bills funding the US Food and Drug Administration (FDA) through user fees includes a provision to add economic considerations to the agency's mission, reports Med Page Today . The provision, put forth by Congressman Mike Rogers (R-MI), would mandate FDA take into account the promotion of economic growth and job creation in addition to its standing mandates to promote public health by ensuring medical products are safe and eff...
  • Dueling Reports Suggest Economic Impact of Regulations Uncertain

    • 17 April 2012
    Two reports issued in April paint markedly different pictures about the effects of regulatory policies on the broader economy. The first, a report commissioned by the US Chamber of Commerce (CoC), a politically powerful trade coalition of businesses, found that concerns about "over-regulation" were "the highest we've seen in the past year." CoC's study of its 536 member and 803 non-member small businesses found 42% of small businesses citing "over-regulation" as their h...