• Regulatory NewsRegulatory News

    CDRH Instructs on Magnetic Field Interference with Shunt Systems

    • 16 July 2019
    Magnetic externally programmable cerebrospinal fluid (CSF) shunt valve settings can inadvertently change when at a distance of fewer than two inches from common magnetic sources such as cell phones, a US Food and Drug Administration (FDA) analysis concludes.
     
  • Regulatory NewsRegulatory News

    CBO Finds Major Savings in FDA Provisions of Senate Health Bill

    • 16 July 2019
    The Congressional Budget Office (CBO) said Tuesday that the Senate’s bill to lower health care costs will reduce the deficit by about $7.5 billion over 10 years, and the sections with US Food and Drug Administration (FDA) changes will reduce the deficit by about $4.6 billion over the same time period.
  • Regulatory NewsRegulatory News

    EC Revises Drug Safety Features Q&A

    • 16 July 2019
    The European Commission last week issued a revised questions and answers guideline on implementing safety features for medicinal products detailed in Commission Delegated Regulation (EU) 2016/161.
  • Regulatory NewsRegulatory News

    FDA Warns Strides Pharma for Uncontrolled Document Shredding

    • 16 July 2019
    The US Food and Drug Administration (FDA) warned Indian generic drugmaker Strides Pharma earlier this month over good manufacturing practice (GMP) violations at its Puducherry facility that included uncontrolled shredding of documents and inadequate investigations into out-of-specification (OOS) test results.
  • Regulatory NewsRegulatory News

    FDA Warns Strides Pharma for Uncontrolled Document Shredding

    • 16 July 2019
    The US Food and Drug Administration (FDA) warned Indian generic drugmaker Strides Pharma earlier this month over good manufacturing practice (GMP) violations at its Puducherry facility that included uncontrolled shredding of documents and inadequate investigations into out-of-specification (OOS) test results.
  • Regulatory NewsRegulatory News

    FDA Proposal to Pull Some Radiological Health Regulations Draws Mixed Reactions

    • 16 July 2019
    A US Food and Drug Administration (FDA) proposal to amend and repeal parts of its radiological health regulations will enable better use of resources and reduce duplication, but clarifications are needed on the recording and reporting requirements, stakeholders argue.
     
  • Regulatory NewsRegulatory News

    FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection

    • 16 July 2019
    The US Food and Drug Administration (FDA) recently opened for comment until 26 August a guideline from the International Council for Harmonisation (ICH) on how to collect safety data in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterized.
  • Regulatory NewsRegulatory News

    FDA Looks for New Device Sterilization Methods

    • 15 July 2019
    Following the closures of contract sterilization facilities that prompted the US Food and Drug Administration (FDA) to alert to the potential for medical device shortages, the agency launched two public innovation challenges Monday to spur sterilization alternatives and reduce emissions.
  • Regulatory NewsRegulatory News

    MHRA Seeks Input on Patient, Public Engagement

    • 15 July 2019
    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday opened a twelve-week public consultation to gather input on its approach to engaging the public, patients, caregivers and health care professionals.
  • Regulatory NewsRegulatory News

    EMA Warns of Dosing Errors With Methotrexate Drugs

    • 15 July 2019
    The European Medicines Agency’s (EMA) on Friday released a set of recommendations for health care professionals to follow to avoid dosing errors with methotrexate-containing medicines.
  • Regulatory NewsRegulatory News

    Gilead and Novartis Seek to Expand What FDA Considers as Real-World Data and Real-World Evidence

    • 15 July 2019
    Just over two months ago, the US Food and Drug Administration (FDA) released draft guidance explaining to drugmakers what constitutes real-world data (RWD) and real-world evidence (RWE) and how to submit such data to the agency.

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  • Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’

    • 18 June 2019
    Swiss notified body (NB) QS ZÜRICH AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain.
     
  • EC Offers Two New Guidance Documents on MDR/IVDR

    • 01 July 2019
    The European Commission (EC) on Monday released one new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro Diagnostic Device Regulation (IVDR), and another guidance on the implant card required by MDR.
  • US and EU Fully Implement Mutual Agreement on GMP Inspections

    • 12 July 2019
    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities.
     
  • EC Cautions on MDR/IVDR Impact on Device Availability

    • 17 June 2019
    In a factsheet posted Monday, the European Commission (EC) acknowledged that the EU’s medical device and in vitro diagnostic regulations (IVDR) “could have consequences for the availability of medical devices for health institutions,” with the potential for some devices to "become temporarily unavailable."
     
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