Regulatory Insights

  1. FDA Issues Draft Guidance On Blood Pressure (BP) Response In Clinical Trials
    9/4/2018

    Familiarize yourself with the new FDA draft guidance on blood pressure response which carries important implications for drug developers.

  2. A Survival Guide To Temperature Data In Life Sciences
    8/22/2018

    Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.

  3. Changes to WHODrug Are Coming – Will You Be Ready?
    8/18/2018

    Why you should prepare now even with nearly a year remaining.

  4. 4 Tips For FDA Submission
    7/16/2018

    What can you do during your study to maximize your chances of success when it comes time to submit?

  5. Thinking Pragmatically About The Future Of Real World Evidence
    6/20/2018

    Questions and concerns as the FDA prepares to develop and implement a program evaluating the potential use of Real World Evidence (RWE) for regulatory decisions.

  6. Regulatory Requirements For Medical Devices In China
    4/24/2018

    Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.

  7. Can Your Clinical Supply Chain Pass The Brexit Pressure Test?
    3/13/2018

    - Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask

  8. Twin Revolutions: Will New Tech Get Along With New Regulations In Clinical Research Technology?
    2/15/2018

    What can be done to that the technology opening new doors in the capture and analysis of clinical data, and the guidance responsible for regulating them, keep up with one another?

  9. Insights Into Medical Device Regulations From MAGI 2017 West
    12/19/2017

    Regulatory experts outline some of the regulatory changes on the horizon for the medical device industry.

  10. Japanese Sponsor Sources Partner For End-To-End Pharmacovigilance Case Processing
    11/29/2017

    Long-standing global relationship and history of quality important factors in selecting their partner to process foreign cases for PMDA submission for studies.