Regulatory Affairs Editorial

31. Moving Your QMS Beyond (Current And Future) Regulatory Expectations: A 7-Step Process 12/27/2018

    Currently, sponsors running clinical trials have established quality management system (QMS) frameworks inclusive of organizational structure, processes, and procedures on the following premise: The QMS helps maintain a company’s compliance to regulations, ultimately with the hopes of ensuring patient safety, product quality, clinical responsibility, and data integrity.

32. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019 12/26/2018

    Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.

33. FDA Hopes To Advance Clinical Testing To Deliver New Cures 12/20/2018

    The FDA notes new diagnostic tests that undergo rigorous FDA review must demonstrate they are analytically and clinically valid. Unfortunately, the majority of laboratory developed tests (LDTs) currently do not demonstrate to FDA that they meet those standards. A new approach may simplify this process.

34. How Can Government Promote Orphan Disease Research? 12/6/2018

    Mallory Factor, chairman of IntraBio, has worked with regulatory agencies in both the U.S. and Europe on matters relating to clinical development programs. In doing so he had the opportunity to observe the obstacles that serve to delay and even restrict novel orphan therapies from getting to patients. He believes orphan drug developers and the FDA must collaborate more closely to bring more treatments to approval.

35. What’s In A Name? Understanding Unmet Medical Need May Help Align Prioritization Strategies 12/4/2018

    Unmet medical need (UMN) is not a new concept, but it is an increasingly important one. Regulators and payers are nudging the industry to steer R&D investments toward areas with higher unmet need and less crowded pipelines.

36. Now That Right To Try Is Law, What Does It Mean To You? 11/29/2018

    On May 30, 2018 President Trump signed Senate Bill 204 into law. The law, more commonly known as Right To Try (RTT), allows certain patients access to investigational drugs outside of clinical trials. Now that it is law, what will RTT mean to you?

37. Key Takeaways From FDA’s New Guidance On First-In-Human Multiple Expansion Cohort Trials 11/8/2018

    The FDA published a new draft guidance on August 10, 2018 entitled, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics. The comment period for the draft guidance closed on October 12, 2018 and approximately 20 comments were submitted to the docket. The guidance provides sponsors with recommendations for designing and conducting first-in-human (FIH) multiple expansion cohort trials within their oncology development programs.

38. Cannabis Trials Move Forward…But Lag In The U.S. 11/5/2018

    For researchers hoping to conduct clinical trials on cannabis-based products, the U.S. is not the most hospitable place. While other countries are legalizing the drug and conducting research on its possible medicinal uses, state and federal regulations on marijuana in the U.S. continue to stymie its use.

39. Emerging Strategies For Pre-Launch Access Programs 10/30/2018

    In recent years, a growing number of pharmaceutical companies have recognized the potential benefits of pre-launch access programs, either as components of later-stage clinical development or early access programs or to support importation of drugs into countries recognizing an FDA or European Medicines Agency (EMA) approval. 

40. Blame Shouldn’t Be Filed In The TMF: A Call For Trial Master File Process Improvement 10/23/2018

    “A bad system will beat a good person every time.”¹ This quote by legendary management thinker W. Edwards Deming introduces the fundamental concept underlying process thinking. Process thinking, as the name implies, is a human factors-derived philosophy concerned with viewing the world through a process-oriented perspective. Processes are the essential components of our systems that enable them to execute their purpose: any set of steps designed to achieve an objective can be considered a process. The wide scope of this definition reflects the abundance of processes in all areas of our lives – both inside and outside the workplace. Based on this definition, a process is an objective-driven task.