REGULATORY ARTICLES

  • New Regulations And Safety Complicate Drug Labeling
    New Regulations And Safety Complicate Drug Labeling

    Multinational pharmaceutical companies have for decades manufactured drugs for global distribution. Nevertheless, the task of labeling is becoming increasingly difficult and time-consuming. 

  • How Will The Federal Right To Try Law Impact Drug Development?
    How Will The Federal Right To Try Law Impact Drug Development?

    The passing of the Right to Try Act came after years of debate among politicians, the pharmaceutical industry, and other stakeholders about the potential legal, ethical, regulatory, and business impacts of RTT. That debate is unlikely to end any time soon.

  • How Recent Regulatory & Payer Developments Impact U.S. Biosimilar Access
    How Recent Regulatory & Payer Developments Impact U.S. Biosimilar Access

    In this second installment of a three-part series, industry stakeholders discuss recent developments in the U.S. marketplace from both the regulatory and payer viewpoints, with an emphasis on how these may lead to opportunities for biosimilar manufacturers.

  • Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture
    Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture

    Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.

  • An Analysis Of 2017 FDA Warning Letters On Data Integrity
    An Analysis Of 2017 FDA Warning Letters On Data Integrity

    Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.

  • FY2017 FDA Drug Inspection Observations And Trends
    FY2017 FDA Drug Inspection Observations And Trends

    This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.

  • Too Little Or Too Late? Perspectives On FDA’s New Serialization Guidances
    Too Little Or Too Late? Perspectives On FDA’s New Serialization Guidances

    Looking forward, the U.S. pharmaceutical industry needs to be aware that the despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.

  • What The 2018 Tax Reform Law Means For Life Sciences
    What The 2018 Tax Reform Law Means For Life Sciences

    Tax reform means more cash on hand, but major changes for R&D expensing, net operating losses, and executive compensation.

  • Batter Up: The Starting 9 GDPR Takeaways For CROs
    Batter Up: The Starting 9 GDPR Takeaways For CROs

    While many of the core data protection responsibilities outlined in the GDPR are not new to organizations involved in research, the GDPR nonetheless will have significant repercussions for CROs. With the baseball season coming up and the GDPR effective date around the corner, here are the “starting nine” GDPR takeaways for CROs.

  • Proactive Quality Systems: FDA Has Made Them A Priority — Has Your Organization?
    Proactive Quality Systems: FDA Has Made Them A Priority — Has Your Organization?

    FDA’s traditional compliance requirements establish a uniform quality system framework, but do not ensure device quality across the ecosystem. Furthermore, a compliance audit will tell a manufacturer whether the system they have established is compliant with current regulations but offers no insight into how they might improve the device, the system, or the development process.

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