Regulatory Insights

  1. 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.

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 Help For Sponsor-Investigators: FDA Issues Draft Guidance On Preparing And Submitting INDs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

  3. 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. 


  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. Catching Up With The Consumerization Of Technology In The Clinical Trial World

    Not too long ago, a clinical operations professional likely enjoyed more powerful technology capabilities at the office than at home. She had a sophisticated email infrastructure, shared calendaring, a high-speed network and maybe a Blackberry.

    At some point during the last 15 years this trend flipped. Suddenly people had better tools in their personal lives and the limitations of their office tools became apparent by comparison – for example, systems that won’t talk to each other, small inbox quotas, file size attachment restrictions, slow email searches and difficult file sharing. Meanwhile, consumer technology rapidly became more sophisticated, available and accessible with collaborative cloud-based tools, personal devices and similar applications to improve the efficiency of everyday tasks.

  9. The Plain Writing Act of 2010: Lessons for Industry

    FDA and other federal agencies are bound by the Plain Writing Act of 2010 to use “clear government communication that the public can understand and use.”  It seems ridiculous that we’d need legislation for such a thing, since “understandable” and “useful” are such obvious and fundamental attributes of communication.  There’s even a companion document, the 118-page Federal Plain Language Guidelines (FPLG). By Laurie Meehan, Polaris Compliance Consultants, Inc.

  10. Patient Reported Outcomes: A Key To Compliance Success Factors

    Subject compliance is a hot topic in the industry right now. Some of the discussions out there can be a little misleading since ‘compliance’ means different things to different people / companies.