REGULATORY ARTICLES

  • After The Failed Trans-Pacific Partnership: What Comes Next?
    After The Failed Trans-Pacific Partnership: What Comes Next?

    The Obama Administration, seeking to expand international trade, negotiated the Trans-Pacific Partnership (TPP) with 11 other Pacific Rim countries. After President Trump assumed office in January, he immediately withdrew the U.S. from the multilateral agreement. The other TPP countries — now known as the TPP 11 — and other Asian countries have since been seeking a replacement low-tariff trade market.

  • Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies
    Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies

    FDA Commissioner Scott Gottlieb has taken the wheel at an exciting time, when insights from genomics are starting to come to fruition and promising new therapies based on new technologies are being developed. This article explores some of the policy changes happening now in the regulatory rare disease space — and shifts we expect to see in the future — as the FDA’s leadership team implements these changes at the agency.

  • How Interested Is The FDA In Real-World Evidence?
    How Interested Is The FDA In Real-World Evidence?

    When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry.

  • State Of Serialization: Where FDA & The Pharma Industry Currently Stand
    State Of Serialization: Where FDA & The Pharma Industry Currently Stand

    For the Drug Supply Chain Security Act to be effective, it requires pharma to institute electronic, interoperable systems that enable stakeholders to identify and trace drugs distributed into the U.S. 

  • What Can Scott Gottlieb Do To Advance The FDA & Clinical Trials?
    What Can Scott Gottlieb Do To Advance The FDA & Clinical Trials?

    On May 11, Scott Gottlieb, M.D., officially became the 23rd commissioner of the U.S. Food and Drug Administration (FDA). Dr. Gottlieb has previous FDA experience, having served as deputy commissioner for medical and scientific affairs, among other positions, during the George W. Bush administration.

  • How The FDA Views Natural Language Processing
    How The FDA Views Natural Language Processing

    According to speakers at an FDA workshop, natural language processing (NLP) can be a useful way to extract meaningful information from unstructured data, such as text and tables from electronic health records (EHRs), journals, and social media, but it isn’t ready for full-scale use.

  • The Supreme Court’s Upcoming Review Of IPR Constitutionality — A Biopharma Perspective
    The Supreme Court’s Upcoming Review Of IPR Constitutionality — A Biopharma Perspective

    IPR provides an adversarial process for challenging patents at the U.S. Patent Office. As of earlier this year, there were over 50 IPR petitions reportedly on file challenging patents relating to the large molecule biopharma space.

  • FDA, PDUFA, And Patient Engagement — What Pharma Companies Need To Know (And Do)
    FDA, PDUFA, And Patient Engagement — What Pharma Companies Need To Know (And Do)

    New regulatory developments at the FDA and beyond allow companies to leverage patient experiences and behaviors to create better products, obtain faster regulatory approvals, and better demonstrate the value of their products over time to payers and reimbursement bodies.

  • Drug/Device Development Changes Imminent: 21st Century Cures Act Becomes Law
    Drug/Device Development Changes Imminent: 21st Century Cures Act Becomes Law

    Learn how the Cures Act is changing the pathways and processes for developing and getting approval for new drugs and devices and new uses for existing products.

  • Responding To Regulatory Inspection Observations: Do’s And Don’ts
    Responding To Regulatory Inspection Observations: Do’s And Don’ts

    Although good auditors base conclusions on facts, emotions will play an important role in how they perceive your company, your leadership, and your quality culture. This is not a precise process, and cultural differences can often sabotage good intent. 

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