Regulatory Affairs Editorial

  1. Follow The Leader: Why Clinical Development Must Transition From Pharma-Led To Patient-Led

    “Patient-led drug development” has matured in recent years from an industry buzzword to a maxim practiced in pockets of pharma organizations each day. Yet, much more can be learned by looking through the patient lens, deeply considering their needs, and focusing on their quality of life. In recent years, companies have galvanized their efforts to develop additional methods for gathering patient input, to redesign clinical programs that improve patient experiences, and to track surrogate measures of “patient-centricity” at key stages.

  2. FDA Form 1572 And Non-U.S. Clinical Trials: To Complete Or Not To Complete?

    As Bob Dylan sang many years ago, “For the times they are a-changin,”1 could be the motto of drug development. Regulations, requirements, and enforcement practices have changed, and industry professionals strive to maintain awareness in order to be compliant. As the number of clinical trial site locations outside of the U.S. has increased — driven by untapped populations, faster recruitment, and lower costs,2 — the challenges have added up. Regionally, the required or anticipated documentation and enforcement of those requirements has changed over time. One document that has recently garnered attention is the FDA Form 15723 and specifically its use by non-U.S. investigators.

  3. Top 5 Strategies To Execute And Document GCP/GVP Vendor Oversight

    Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019.

  4. Taking Control Of Quality Tolerance Limits In Clinical Trials

    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) regulations have created a buzz within the industry regarding newly required expectations for quality tolerance limits (QTLs) when conducting good clinical practice (GCP) clinical trials. QTLs have historically been required for good manufacturing practice (GMP) activities, inferring limits at which significant actions must be taken to ensure the manufactured product achieves quality and usability limits.

  5. Moving Your QMS Beyond (Current And Future) Regulatory Expectations: A 7-Step Process

    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.

  6. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019

    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.

  7. FDA Hopes To Advance Clinical Testing To Deliver New Cures

    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.

  8. How Can Government Promote Orphan Disease Research?

    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.

  9. What’s In A Name? Understanding Unmet Medical Need May Help Align Prioritization Strategies

    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.

  10. Now That Right To Try Is Law, What Does It Mean To You?

    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?