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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    ‘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...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Postmarket Device Surveillance

    The US Food and Drug Administration (FDA) on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices. The guidance comes as the Government Accountability Office (GAO) said last October that 90% of the postmarket surveillance studies FDA ordered over the past seven years were categorized as inactive, though some...
  • Regulatory NewsRegulatory News

    FDA Warns Wearable Exoskeleton Manufacturer Over Post-Market Surveillance Failures

    Israel-based Argo Medical Technologies has been warned by the US Food and Drug Administration (FDA) after its failure to conduct post-market surveillance studies for its ReWalk device, which is meant to help individuals with spinal cord injuries to stand upright, walk, turn, and climb and descend stairs. The warning letter is for the company’s Massachusetts site, which opened in 2012, and details how the company consistently avoided FDA requests for more than a year. T...
  • Regulatory NewsRegulatory News

    Indian Parliament Proposes Extending Price Caps to all Drugs

    Just weeks after India's drug pricing chief was ousted, a parliamentary committee has proposed expanding price caps to all drugs. Background In India, the price of drugs listed as essential medicines is capped by the National Pharmaceutical Pricing Authority (NPPA) under the country's Drug Price Control Order (DPCO) . The amount these drugs can be sold for is indexed to average wholesale prices of similar products, and can only be increased once per year, as was th...
  • Regulatory NewsRegulatory News

    US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

    A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends. Background The report , authored by the President's Council of Advisors on Science and Technology (PCAST) and released on 18 September 2014, comes just as two troubling trends are intersecting. The first: Antibiotic resistance, which government officials blame for ...
  • Regulatory NewsRegulatory News

    Digging Deeper into China's New Medical Device Registration Requirements

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process. CFDA  Administrative Order No. 4  covers new and revised requirements for Class I, II and III device registrations in China that will take effec...
  • Feature ArticlesFeature Articles

    China’s Order 650 and its Impact on Medical Device Regulation

    After recent State Council reforms, the China Food and Drug Administration (CFDA) became the singular authority on medical device supervision. On 31 March 2014, the Chinese government finally released Order 650 (former Order 276), Regulations for the Supervision and Administration of Medical Devices. The order, effective 1 June 2014, sets the fundamental framework and orientation on medical device supervision and administration in China. Eighty articles determine ...
  • New Executive Order Directs Agencies to Identify and Reduce 'Regulatory Burdens'

    • 10 May 2012
    The White House has released a new executive order directing federal agencies to identify and reduce "regulatory burdens" in their respective organizations, noting the "challenging economic times" the US is traversing. President Barack Obama's executive order, "Identifying and Reducing Regulatory Burdens", builds upon an existing order by the president ordering agencies to periodically review existing significant regulations and find efficiencies within them. Obama's st...
  • Obama Signs Order Promoting International Regulatory Cooperation

    US President Barack Obama signed a new Executive Order on 1 May that the White House hopes will promote international regulatory harmonization and reduce costly misalignments that stifle "economic growth, innovation, competitiveness and job creation." "In an increasingly global economy, international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting" a least-burdensome approach to regulatio...
  • FDA, Other Agencies Asked to Consider 'Cumulative' Impact of Regulations

    The Office of Information and Regulatory Affairs (OIRA), the federal agency tasked with overseeing and approving all regulations in the US, sent notice to all federal agencies this week calling on them to "take account of the cumulative effects of new and existing rules." In a letter dated 20 March, OIRA Administrator Cass Sunstein noted the effects of regulations on companies, and asked federal agencies to take steps to "reduce redundant, overlapping, and inconsistent r...
  • FDA Releases Order to Protect Antimicrobial Drug From Use in Food Animals

    The US Food and Drug Administration today released an order, titled, " New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition ", that is aimed at prohibiting the off-label use of cephalosporin antimicrobial drugs in certain food-producing animals. The agency found that off-label use of the antimicrobial in food-producing animals was likely to be unsafe and represent a risk to the public. The rule follows an attempt to regulate the antimi...