• Regulatory NewsRegulatory News

    Asia Regulatory Roundup: New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections

    • 11 December 2018
    Regulators in New Zealand have reaffirmed their intention to reclassify modified-release paracetamol as a restricted medicine. Officials proposed strengthening the restrictions on the medicine earlier this year and stuck with their decision despite respondents objecting to the reclassification ruling and how it was reached.
     
  • Regulatory NewsRegulatory News

    FDA Warns China’s Zhejiang Huahai Over Failures to Detect Impurities in Valsartan API Batches

    • 11 December 2018
    China-based Zhejiang Huahai Pharmaceuticals drew a US Food and Drug Administration (FDA) warning letter over failures to conduct investigations into impurities classified as probable human carcinogens.
     
  • Regulatory NewsRegulatory News

    House Floats Five Year Extension of Medical Device Tax

    • 11 December 2018
    The widely unpopular medical device excise tax would be delayed for another five years under a tax relief package introduced by the US House Ways and Means Committee on Monday.
     
  • Feature ArticlesFeature Articles

    Safety First

    • 11 December 2018
    This article reviews the development of global Good Distribution Practices (GDPs) against the background of an increasingly complex pharmaceutical supply chain, five years after the initial implementation of the extended EU GDP Guideline.
  • Regulatory NewsRegulatory News

    FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

    • 11 December 2018
    The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product.
     
  • ReconRecon

    Recon: Boehringer to Cut 300 Jobs in France

    • 11 December 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
  • Regulatory NewsRegulatory News

    Duodenoscope Reprocessing: Interim Study Results Indicate Higher Contamination Rates

    • 10 December 2018
    Interim results from the US Food and Drug Administration’s (FDA) mandated postmarket surveillance studies of duodenoscopes indicated a “higher-than-anticipated contamination rates after reprocessing,” FDA said on Monday.
     

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