• 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...
  • Regulatory NewsRegulatory News

    Final Regulation Makes it Easier for FDA to Seize Drugs at the Border

    The US Food and Drug Administration (FDA) is finalizing without change a proposed regulation introduced last year which would establish an administrative detention process for pharmaceutical products it believes are adulterated or misbranded. Background The rule is borne from the  Food and Drug Administration Safety and Innovation Act (FDASIA) , Section 709 ("Administrative Detention") of which ordered FDA to promulgate a final regulation within two years of the passage...
  • FDA Moves to Close Glaring Loophole in Current Drug Import System

    A proposed rule issued by the US Food and Drug Administration (FDA) would make it easier for the agency to destroy low-value drugs refused admission into the US under federal law. Background: Import Regulation The backbone of pharmaceutical regulation in the US is the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Section 801(b) of the FD&C Act , FDA is permitted to refuse to allow the import or entry of any drug that has not been approved (under Sect...
  • Filing Review Process to See Changes Under Proposed CDRH Guidance

    • 30 July 2012
    The US Food and Drug Administration (FDA) on 30 July released new draft guidance aimed at reducing the variability and subjectivity of when premarket applications (PMAs) submitted to the Center for Devices and Radiological Health (CDRH) are deemed to be "administratively complete." The draft guidance, Acceptance and Filing Review for Premarket Approval Applications , is particularly aimed at "assuring the consistency of our acceptance and filing decisions," FDA expl...
  • EPA Case Could Imperil FDA Warning Letters

    A unanimous decision last week by the Supreme Court of the United States (SCOTUS) against the US Environmental Protection Agency (EPA) could place warnings letters sent by the US Food and Drug Administration (FDA) into a quagmire of litigation, report various sources. In Sackett v. EPA , SCOTUS ruled the Administrative Procedure Act-the act governing how FDA and other federal agencies create regulations and make decisions-did not preclude the litigants from immediately ...