REGULATORY ARTICLES

  • 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the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.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.

  • An Analysis Of Regulatory Reforms In China’s Pharmaceutical Market
    An Analysis Of Regulatory Reforms In China’s Pharmaceutical Market

    Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.

  • 6 Public Policy Changes To Ensure A Competitive Biosimilar Market
    6 Public Policy Changes To Ensure A Competitive Biosimilar Market

    Prescription drug spending increases — fueled by high launch prices for new therapies and price increases for existing brand-name drugs — are contributing to unsustainable healthcare cost growth across the country. In addition to straining the healthcare system overall, high drug prices also place financial burdens on patients who rely on prescription medicines to treat and manage serious and chronic medical conditions.

  • 3 Tips To Get The Best Bang For Your Mock Inspection Buck
    3 Tips To Get The Best Bang For Your Mock Inspection Buck

    Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.

  • Why You Should Engage With Regulatory Early In Product Development
    Why You Should Engage With Regulatory Early In Product Development

    Involving regulatory affairs early in the development process facilitates execution of the development pathway while considering both regulatory requirements and the company’s business needs.

More regulatory articles