REGULATORY ARTICLES

  • The Importance Of Harmonizing Tariff Classification For Clinical Trial Supplies
    The Importance Of Harmonizing Tariff Classification For Clinical Trial Supplies

    Trade tariffs can significantly impact the cost of importing and exporting investigational products and ancillary supplies for clinical trials. As such, it is important that companies consider harmonized tariff classification to ensure no money is left on the table.

  • Beyond The FDA Guidance:  Practical Considerations For Quality Agreements
    Beyond The FDA Guidance: Practical Considerations For Quality Agreements

    Much has been written in recent months about the FDA’s final guidance for industry, Contract Manufacturing Arrangement for Drugs:  Quality Agreements, issued in November 2016.  Recently, a thorough assessment of the guidance requirements and gaps was published on this website. (See FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say) and Examining FDA's New Quality Agreement Guidance.)

  • Building A Productive Relationship With FDA: Beyond The Science
    Building A Productive Relationship With FDA: Beyond The Science

    Whether your relationship with the FDA starts with pre-IND feedback or simply with an IND submission itself, these early interactions will likely form the basis for a long (and hopefully happy) marriage.  After all, this liaison could very well last beyond submission and initial approval of a marketing application to include additional trials relevant to the drug’s development and labeling.  As there is no manual available for building an effective and collegial relationship with the FDA, this article offers helpful tips to assist sponsors in establishing and maintaining this critical union.

  • Biopharma IPR Trends
    Biopharma IPR Trends

    It has been almost five years since post-grant proceedings, including inter partes reviews (IPR), were implemented under the America Invents Act as an alternative to patent litigation for challenging granted patents. Taking place before the Patent Trial and Appeal Board (PTAB) at the U.S. Patent and Trademark Office, these proceedings quickly gained the reputation of being patent “death squads,” because they resulted in surprisingly high rates of patent cancellation and therefore became a complement to most patent litigations.

  • What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?
    What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?

    This article presents the most recent GMP inspection data from CDER and MHRA (Medicines and Healthcare Products Regulatory Agency).  The CDER data and the MHRA data come from GMP inspections conducted in 2016.

  • Impact Of International Trade Regulations
    Impact Of International Trade Regulations

    The significant number of national and international trade regulations are challenging for the development of logistics strategies for global clinical research. Identifying the similarities, differences and obstacles pharmaceutical companies face while importing and exporting medicinal products for clinical trials creates an opportunity to streamline the process, remove barriers, and improve efficiency.

  • CMS’ Coverage Gap Is A Significant Challenge For Biosimilars
    CMS’ Coverage Gap Is A Significant Challenge For Biosimilars

    Today it is hard to read anything about specialty drugs without a mention of the potential cost savings offered by biosimilars. Estimates of their potential savings vary – on the high end, some estimates suggest a savings of $66 billion by 2024.1 While stakeholders from patients to physicians, payers, and policymakers would like to realize the full potential of biosimilars in the United States, the challenge that remains is ensuring that reimbursement incentives are adequate to ensure their uptake and long-term utilization.

  • Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech
    Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech

    Within just a few days of taking office, President Trump launched his deregulatory agenda, and he has now issued several executive orders that build on each other. This article analyzes the executive orders and the Office of Management and Budget’s implementation guidance to agencies — and offers insights on their implications for the FDA and innovators.

  • An FDA Perspective On Patient Diversity In Clinical Trials
    An FDA Perspective On Patient Diversity In Clinical Trials

    Since the late nineteenth century, it has been well-known that individuals can vary widely in their responses to the same medication. Yet, accurately predicting and addressing the effects of that variability during drug development has continued to bedevil researchers, drug sponsors, and regulators.

  • USP Keeps Pharmaceutical Quality In Focus
    USP Keeps Pharmaceutical Quality In Focus

    Fueled by its nearly 200-year history, the USP is taking a new look at the value and execution of pharmaceutical quality

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