Regulatory Insights

  1. Regulatory Change Is Coming in the EU – Will You Be Ready?
    10/18/2017

    As the global reach of clinical trials has increased, and with the deadline for EU compliance quickly arriving, many in pharma are finding themselves in a dilemma.

  2. Do THIS To Shorten Your Clinical Trial
    10/3/2017

    With sponsors facing increasing pressure to reduce drug prices and bring therapies to patients faster, follow these tips to shorten your clinical development process.

  3. 10 Things To Remember About The QP Role And Process
    9/19/2017

    The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.

  4. Top Brexit Questions Asked by Clinical Supply Professionals at the 2017 Sherpa Summer Seminar
    8/30/2017

    Based on their survey of San Diego's clinical supply community, there are a lot of concerns around Brexit's impact on clinical supply. Sherpa took the top questions asked by their Sherpa Summer Seminar audience, and answered them in this Q&A.

  5. Brexit Causing Uncertainty For Clinical Supply
    8/29/2017

    John Shillingford, Ph.D., Independent Consultant, communicates some concerns that sponsor companies should consider as they consider holding clinical trials in the EU or the UK in 2019 (when Brexit is scheduled to be official).

  6. A Wake-Up Call For APAC: FDA Requires Electronic Submissions By 2017
    8/17/2016

    The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.

  7. Do Your BioPharma Analytical Methods Hold Up To Regulatory Scrutiny?
    9/1/2015

    As FDA guidelines evolve and drug products on the market begin to age, Bio/Pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations.

  8. Help For Sponsor-Investigators: FDA Issues Draft Guidance On Preparing And Submitting INDs
    6/1/2015

    This guidance is directed primarily at those sponsor-investigators who are seeking to evaluate a drug that is either currently approved or is being investigated under an existing IND for a different indication. A sponsor-investigator must comply with FDA regulations applicable to both a sponsor and investigator.

  9. The Ongoing Push For Human Abuse Liability Studies In The EU
    5/26/2015

    Human Abuse Liability (HAL) studies use clinical procedures that were initially developed in the United States. European nations have had little experience in developing and applying these techniques, which is leading some to question whether more thorough testing could have forestalled some difficulties with addiction, diversion, and other societal harms. 

     

  10. 4 Regulatory Considerations For Using Social And Digital Media In Clinical Trial Patient Recruitment
    5/19/2015

    Social media and digital media can have a much more informal feel than traditional advertising venues, like a newspaper or radio ad. By Kristen Snipes, Project Director, Rho