• Regulatory NewsRegulatory News

    FDA Kicks Off List of 503A Bulk Drug Substances List

    • 15 February 2019
    Six bulk drug substances added to the US Food and Drug Administration (FDA) list of substances can, for the first time, be legally used to compound drugs under a final rule issued by FDA on Friday.
     
  • Regulatory NewsRegulatory News

    CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

    • 15 February 2019
    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued draft guidance Friday to standardize a mechanism for a medical device establishment to request nonbinding feedback on actions such establishments propose to take to address an FDA Form 483.
  • Regulatory NewsRegulatory News

    CGT Designations: FDA Explains Process in New Draft Guidance

    • 15 February 2019
    The US Food and Drug Administration (FDA) on Friday released draft guidance providing information on how sponsors can apply for competitive generic therapy (CGT) designations and when they may be eligible for CGT exclusivity.
     
  • Regulatory NewsRegulatory News

    Update: Appropriations Bill Would Give FDA $269M Boost Over FY2018 Budget

    • 15 February 2019
    The House and Senate passed a seven-bill spending package on Thursday to fund large portions of the federal government through FY2019. And President Donald Trump has said he will sign the bill.
  • Regulatory NewsRegulatory News

    CDER Plots Established Conditions Pilot

    • 14 February 2019
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Thursday announced a new pilot program where sponsors can propose explicit established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).
     
  • Regulatory NewsRegulatory News

    DITTA Pinpoints Cybersecurity Best Practices Amid IMDRF Work

    • 14 February 2019
    The industry group that set forth the new work item for a globally harmonized approach to medical device cybersecurity, which is currently under development, released a new white paper that provides an overview of best cybersecurity practices in medical technology manufacturing.
     
  • Regulatory NewsRegulatory News

    Bipartisan Group of Lawmakers Urge Permanent Repeal of Device Tax

    • 14 February 2019
    A bipartisan team of eight Congressional leaders are circulating a “Dear Colleague” letter to urge fellow members of Congress to permanently repeal of the 2.3% medical device excise tax before it is reinstated next year.
     
  • Regulatory NewsRegulatory News

    Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional

    • 14 February 2019
    Drugmakers and trade groups have raised questions with two US Food and Drug Administration (FDA) guidance documents on biosimilars, including one explaining how FDA plans to transfer drugs previously approved under new drug applications (NDAs) to be biologic license applications (BLAs).
     

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