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  • Regulatory NewsRegulatory News

    Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says

    Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they? Jeff Shuren, director of CDRH late Monday told attendees of JP Morgan’s annual conference that he thinks fear and a limited amount of CMS staff are two reasons that the parallel review ...
  • Regulatory NewsRegulatory News

    USP Signs Agreement With Russian Drug Regulator to Continue Developing Quality Standards

    USP CSO Jaap Venema (right) signs agreement with Russian FDA Roszdravnadzor. The US Pharmacopeial Convention (USP) and Russia's medical products regulator forged a three-year memorandum of understanding (MOU) earlier this week that will focus on harmonizing major pharmacopeial requirements and promoting the use of modern laboratory standards, among other things. The agreement, which is an extension of an existing MOU instituted in 2009, means USP and the Federal...
  • In Reversal, FDA to no Longer Publish Agreements in Federal Register

    In a reversal, the US Food and Drug Administration (FDA) has released a final rule regarding the posting of all memoranda of understanding the agency signs with other agencies and organizations, saying it will no longer post them in the Federal Register . The agency would previously make such agreements available in the Federal Register and on its website, but the duplicative posting was a drain on the agency's time and resources, FDA wrote. The agreements establish...
  • UPDATED: FDA Withdraws Final Rule After Receiving 'Significant Adverse Comment'

    • 26 June 2012
    Sometimes it takes just a single powerful argument to derail an intended final rule. The US Food and Drug Administration (FDA) announced on 27 June its withdrawal of a final rule as the result of a "significant adverse comment." The agency did not elaborate on the comment or its significance, but the intended final rule was published on 23 March 2012. Entitled, "Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agen...
  • Brazil: Regulation Seen as Supporting Social And Economic Development

    Brazil's national regulatory agency, Anvisa, and the Ministry of health have announced the joint recognition of regulation as a benefit for social and economic development under a new Memorandum of Understanding published 13 June. Anvisa had argued on behalf of the arrangement, saying its surveillance activities were "strategic" and worked to advance more than just good products. "Every step we take in the surveillance area, multiply the reduction of spending sustainabil...
  • China: China Signs MOU with the Ukraine

    On 17 May 2012, Yin Li, commissioner of the Chinese State Food and Drug Administration's (SFDA), signed a bilateral Memorandum of Understanding ( MOU)  with the Deputy Director of the Ukrainian State Drug Administration, Andrei Zakharash.  The MOU will strengthen bilateral cooperation in regulatory matters, especially those relating to pharmaceuticals. Representatives from SFDA's International Cooperation Department and the head of SFDA's Drug Registration Depa...
  • China Signs MOU with the Netherlands

    • 07 May 2012
    China's State Food and Drug Administration has further expanded its international collaborative efforts in regulatory matters by concluding a Memorandum of Understanding (MOU) with the Ministry of Health of the Netherlands. The new MOU calls for expanded cooperation between the two countries on matters relating to the regulation of drugs and medical devices. A Dutch company had exported to China breast implants containing industrial grade silicone that were supplied by...
  • FDA Altering Policies on Publishing Memoranda of Understanding

    The US Food and Drug Administration (FDA) announced Friday it will stop publishing written agreements and memoranda of understanding (MOU's) in the Federal Register , and will instead be opting to publish the agreement solely on its website. The 23 March Federal Register final rule claims the existing regulatory policy is no longer necessary, and eliminates the requirement effective 6 August 2012. FDA currently uses MOUs to generate agreements between US agencies and...