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    Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Forms Leadership Group to Reform Drug Pricing Legislation, NPPA India has convened a committee to consider reforms to drug pricing legislation and the agency that enforces the rules. Officials at the Department of Pharmaceuticals took the step in response to feedback from regulators and industry about the shortcomings of the existing pricing legislation and mech...
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    Democrats Propose Wide-Ranging Bill to Lower Drug Costs

    More than a dozen House and Senate Democrats late Wednesday unveiled a host of new provisions to bring down the rising cost of pharmaceuticals, offering up many ideas that have been publicly opposed by the pharmaceutical industry. The bill, known as the Improving Access to Affordable Prescription Drugs Act , was introduced alongside a House companion , though neither is likely to gain much traction in the Republican-controlled House and Senate. However, some of the b...
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    UPDATE: RAPS Seeks Authors for EU Fundamentals Book Deadline Extended

    • 30 March 2017
    The eighth edition of Fundamentals of EU Regulatory Affairs will be published in December 2017. RAPS currently is seeking authors for chapters, which will be due no later than 1 August 2017. If you would like to contribute to this book, please review the list of currently available chapters below and send your CV and your preferred chapter(s) to Pam Jones, senior editor, at pjones@raps.org or submit a volunteer application online. Emails or applications must be...
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    Canada to Require Drugmakers to Publicly Disclose Drug Shortages

    Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca. “As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a...
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    Trump Working on ‘New System’ to Increase Drug Competition

    President Donald Trump tweeted Tuesday morning that he’s “working on a new system where there will be competition in the Drug Industry,” though how such a system would work alongside the current generic drug and biosimilar competitors, remains to be understood. On what such a system might entail, a White House spokesman told Focus : "The President has been steadfast in his commitment to reducing the regulatory burden on everyday Americans. As demonstrated through the ...
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    Trump Criticizes ‘Slow and Burdensome’ FDA Approval Process

    In a joint session of Congress on Tuesday evening, President Donald Trump repeated his attacks on the US Food and Drug Administration’s (FDA) “slow and burdensome approval process,” promising to “slash the restraints, not just at FDA but across our government.” The speech, widely regarded as a positive step away from his more off-the-cuff rallying cries, pointed to Megan Crowley, who was in attendance in the Capitol and is diagnosed with a rare condition known as Po...
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    Trump Targets Regulations Again With New Executive Order

    President Donald Trump on Friday took another swipe at federal regulations, signing an executive order that requires all federal agencies to create task forces to help “alleviate unnecessary regulatory burdens placed on the American people.” The added layer of bureaucracy created by the executive order is called upon to, within two months, designate an agency official as its Regulatory Reform Officer (RRO). Each RRO shall oversee the implementation of regulatory reform ...
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    Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Medical Device Rules, Marking Long-Sought Split From Drug Regulation India has finalized its long-awaited medical device rules. The legislation is set to ease regulation of medical device manufacturing and development by freeing the industry from rules designed for the pharmaceutical sector. Until now, a lack of dedicated regulations covering the majori...
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    Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance

    The Office of Management and Budget (OMB) late last week offered guidance to federal agencies, including the US Food and Drug Administration (FDA), trying to figure out how the new “two out, one in” executive order (EO) will impact their issuance of guidance and rulemakings moving forward. The Q&A offers some clarity and boundaries for the EO signed last Monday, noting: “The EO’s requirements for Fiscal Year 2017 apply only to those significant regulatory actions, as d...
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    Trump Pledges to Gut FDA: Which Regulations Need to Go?

    With an executive order (EO) and comments from President Donald Trump yesterday calling for a massive overhaul of US Food and Drug Administration (FDA) regulations, legal experts and former FDA officials are offering some practical and creative ways the agency could clean house. And before this dive into what FDA might or even could do following the signing of this EO , it is important to remember a constant refrain from all experts Focus spoke with: FDA codifies stat...
  • Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated

    In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.” The comments, which came before the meeting with CEOs from industry group PhRMA, Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so t...
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    ‘Two Out, One In’: Trump Signs Executive Order to Repeal Regulations

    President Donald Trump on Monday signed an executive order (EO) that would require all government agencies to eliminate two regulations for every new regulation instituted. The order , which White House officials characterized as a “one in, two out” plan to benefit small businesses, will likely impact the US Food and Drug Administration (FDA) as it applies to every agency but those related to military or national security-related branches of the federal government or ot...