Regulatory Insights

  1. Brexit Causing Uncertainty For Clinical Supply

    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).

  2. How To Use A Proactive Risk Management Approach For ICH E6 Compliance

    This article discusses how the ICH has changed with the recently approved Integrated Addendum to ICH E6(R1): Guidelines for Good Clinical Practice E6(R2) and outlines some major areas where sponsors can develop more efficient approaches.

  3. A Wake-Up Call For APAC: FDA Requires Electronic Submissions By 2017

    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.

  4. Do Your BioPharma Analytical Methods Hold Up To Regulatory Scrutiny?

    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.

  5. Help For Sponsor-Investigators: FDA Issues Draft Guidance On Preparing And Submitting INDs

    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.

  6. The Ongoing Push For Human Abuse Liability Studies In The EU

    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. 


  7. 4 Regulatory Considerations For Using Social And Digital Media In Clinical Trial Patient Recruitment

    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

  8. Clinical Program Partnering Leads To Regulatory Approval For Retina Drug

    A small biotech company partnered with Chiltern to perform full services across over 15 projects for their entire clinical program in retinal indications starting at Phase II.

  9. Biosimilars In Emerging Markets Is It A Level Playing Field?

    It’s a chilling fact: One irresponsible company could seriously damage, or even destroy the biosimilar field. A single company cutting corners with under-regulated, lower-quality development could create an inferior product that harms or kills patients.

  10. 4 Ways You Can Overcome Roadblocks To Technology Adoption In Clinical Trials

    Technology continues to advance at almost breakneck speeds. Not only are these advancements surpassing anything we could have imagined just 10 or 20 years ago, they are touching every professional field, including Life Sciences. More advanced computers, displays, and software programs are replacing paper, cards, files, and binders in libraries, banks, and professional offices around the world. Yet despite a clear need and desire to move in a paperless direction, clinical trials still lag far behind other highly regulated industries.