Regulatory Insights

  1. China’s Recent Drug Scandals: What Do They Mean For Foreign Drug Makers?
    2/20/2019

    Recent scandals surrounding Chinese drug manufacturers have Chinese nationals looking outward, and have even sparked regulatory reforms. This lost faith in local drug companies begs the question: what does this mean for foreign investors?

  2. 505 (b)(2) vs. ANDA: How Complex Drugs Fit In
    2/7/2019

    Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

  3. Industry Thought Leaders Share Clinical Trial Disclosure And Transparency Predictions For 2019
    1/31/2019

    With buzzwords such as patient centricity, patient experience and health literacy rapidly becoming the new reality, executives from TrialScope share their predictions for the coming year.

     

  4. With Investors’ Eyes On Biotechs, Biotechs Must Keep Their Eyes On Transparency
    1/31/2019

    Small and mid-size pharmaceutical companies seeking funding or interested in being acquired up by a larger pharma company should not ignore the importance of disclosure, transparency and compliance when it comes to financial matters.

  5. How Disclosure As A Service Can Reduce The Burden And Raise The Bar For Transparency
    1/31/2019

    With the help of software and services, sponsors can expand their options. Sponsors struggling to maintain compliance can do so more efficiently. Those whose goal is to overachieve can turn such aspirations into reality.

  6. Rapid Change, Real Promise: The Future Of Rare Oncology Research
    12/26/2018

    Insight on the major issues being raised in the rare oncology space today, including patient perspectives on rare cancer research, innovative trial designs, the regulatory landscape, and pending legislation that may impact how studies are conducted.

  7. Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs
    12/26/2018

    Explore the many aspects a company must consider in planning and executing an early-phase oncology trial of this hypothetical compound, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints.

  8. Tracking And Managing Global Disclosure Performance
    10/4/2018

    The following paper discusses the challenges of tracking global disclosure performance and how clinical trial sponsors can use Atlas Global Compliance to manage track and reduce the risks of non‐compliance.

  9. One Source Drives One Process For Clinical Trial Transparency
    10/4/2018

    Sponsor was challenged with lengthy, resource-intensive processes to support compliance in clinical trial registration and results reporting.

  10. Improving Compliance While Reducing Resources
    10/4/2018

    A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov).