REGULATORY ARTICLES

  • 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

    It’s Friday, it’s late, and you are just leaving for the weekend. The inspection you hosted two weeks ago remains a painful memory. The exit meeting didn’t go well — five major observations, all relating to your quality system. When your boss enters your office, you know it’s not to wish you a good weekend. 

  • Seeking A Smooth Transition To The New EU MDR? (Then Start Complying Now)
    Seeking A Smooth Transition To The New EU MDR? (Then Start Complying Now)

    The new regulation has a word count nearly four times higher than its predecessor, the Medical Devices Directive (MDD), contains five more annexes, and uses the word “safety” 290 times, rather than just 40 times. 

  • Genentech Masters Breakthrough Therapy Designation
    Genentech Masters Breakthrough Therapy Designation

    Genentech has garnered 15 Breakthrough Therapy Designations for its medicines since 2013, which is more than any other company. Jeffrey Siegel, senior group medical director for Genentech, believes this success reflects the company’s focus on developing new approaches to address unmet medical needs.

  • 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

    Many sponsors, particularly small to midsize organizations, opt to use their CMO’s boilerplate quality agreement. These agreements in many cases are compliant with the standards, but they usually lack many of the practical details to ensure an effective relationship with clear expectations.

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

    At the end of the day (or several years), sponsors and the FDA ideally work collaboratively during the drug development process, having a shared public health goal of making safe, effective, and high-quality drugs available to the American public as quickly as possible.

  • Enforcement & Regulatory Responses To The Pharmacy Benefit Manager Debate
    Enforcement & Regulatory Responses To The Pharmacy Benefit Manager Debate

    The first part of this article introduced pharmacy benefit managers (PBMs) and their business model and explored the monopolization concerns in this market. The focus now turns to state and federal actions regarding PBMs.

  • 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.

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