Regulatory Affairs Editorial

31. Teva Develops First FDA-Approved Digitally-Integrated Inhaler 1/8/2020

    Two challenges have plagued asthma sufferers and researchers for year. The first is patients not adhering to their maintenance medication. The other is patients not using proper inhaler technique. A new digitally-integrated inhaler from Teva hopes to eliminate both problems.

32. Practical Considerations For Adaptive Designs In Clinical Trials 1/7/2020

    The life sciences industry and academic world seem to produce incredible scientific breakthroughs on a daily, if not hourly, basis these days. The pace of scientific breakthrough is mesmerizing, as a dazzling variety of technologies and studies have helped humans understand the underlying causes of disease. Whether those causes are genetic, environmental, or behavioral, it seems that we have an arsenal of tools to understand much more than ever how we can meet unmet human health needs. From the ambitious (at the time) Human Genome Project to the current application of machine learning and artificial intelligence to vast integrated data sets, it would seem that humans could be on the cusp of fundamentally altering the quality and longevity of human life.

33. Meeting Clinical Trial Data Requirements In Asian Markets 1/3/2020

    Drug sponsors looking to enter the pharmaceutical markets of China, Japan, and India will be faced with regulatory requirements specific to the design, collection, and management of clinical information that are unique for each marketplace. We’ll discuss potential strategies for dealing with these requirements, from planning to clinical studies, to successfully launch a product that’s ready for Asia.

34. Pediatric Oncology Trials Under FDARA Section 504 — How To Prepare 12/12/2019

    Although the development of cancer drugs for children is riddled with challenges, the requirements in Section 504 of the FDA Reauthorization Act of 2017 (FDARA) represent a significant paradigm shift in pediatric oncology. Historically, legislative initiatives that support pediatric drug development have had much less impact in oncology than in other clinical areas.

35. SOP Remediation: When Reinventing The Wheel Is The Best Approach 11/12/2019

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.

36. The EU Qualified Person (QP) Demystified 10/29/2019

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons may be perceived as a challenge to overcome, because their role and responsibilities are not fully understood.

37. Preparing For Health Authority Inspections: 4 Keys To Inspection Readiness 10/22/2019

    Health authority inspections are one of the most stress-inducing experiences a sponsor, CRO, or site will go through. The mere mention of inspections is enough to throw some people into full on panic-mode. While preparing for an inspection will never be a care- and stress-free process, there are appropriate ways to get your organization ready for one without adding another layer of stress and frustration.

38. 5 Narrative Elements That Will Reveal The Masterpiece In Your TMF 10/15/2019

    In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the data passively generated through modern clinical applications. Although helpful to address specific concerns, especially those related to completeness, these metrics are often unintuitive and do not readily describe the aspects of a clinical trial most instrumental for TMF health.

39. Rebiotix Works With Regulators To Define A New Clinical Pathway 10/14/2019

    Rebiotix, a Ferring company, hopes to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. The company is developing their proprietary MRT drug platform, which uses a defined manufacturing process and quality control parameters to assess the impact of human-derived microbiota therapies on patient health and disease.

40. Collaborating With Patients: 3 Key Considerations For Drug Sponsors 10/10/2019

    Historically, patient involvement has been vital in the design and execution of clinical trials, but in recent years there has been an increased desire to engage patients from start to finish during the drug development process. Today, patients are empowered by technological advances that have given them access to more information than ever before, especially regarding diseases and drug development.