Regulatory Affairs Editorial

  1. 5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts

    When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree.

  2. The Benefits Of Real-World Evidence (RWE) For Biosimilars And Special Populations

    While RWE can serve as a key complement to clinical studies in the development of a wide range of therapies, there are specific instances for which RWE is particularly beneficial and indeed the only available evidence to support regulatory approval. RWE has the potential to spur the uptake of biosimilars in the U.S. market and to provide information on a drug’s efficacy and safety in special populations that may otherwise be excluded from clinical trial studies.

  3. FDA’s Gottlieb Addresses Effort to Advance New Innovations

    In a nearly 3,700 word missive by Scott Gottlieb, posted on August 29, 2018, the FDA commissioner attempts to bring some clarity to efforts by the agency to bring more innovation into the drug development process. Gottlieb notes innovative new technology platforms, such as digital health, targeted medicines, and regenerative medicine, including cell and gene therapies products, are helping the industry advance drug development.

  4. Initiating Multinational Clinical Trials: Major Differences Between The U.S. And EU

    There are significant differences between the U.S. and the EU with respect to the process of gaining regulatory approvals for initiating clinical trials of a new (unapproved) medication. Those differences relate to the initial regulatory submission, review, and approval process and the process for obtaining institutional review board / central ethics committee approval to initiate the clinical trial.

  5. 4 Pitfalls To Avoid When Developing GCP SOPs

    This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.

  6. 10 Key Ingredients For Small Pharma GCP Quality Systems

    Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.

  7. Will Profit Motive Be The First Big Test For RTT Legislation?

    One of the first lessons I learned taking an economics class was the law of unintended consequences. The law seems to hold true time and time again. Case in point: The Right-To-Try (RTT) legislation recently passed by the House and Senate and signed into law by President Trump.

  8. How Will The Federal Right To Try Law Impact Drug Development?

    The passing of the Right to Try Act came after years of debate among politicians, the pharmaceutical industry, and other stakeholders about the potential legal, ethical, regulatory, and business impacts of RTT. That debate is unlikely to end any time soon.

  9. Employing GMP Techniques In GCP For More Robust, Compliant Clinical Studies

    Most of my career has been on the good manufacturing practices (GMP) side of industry, where, despite moments of ambiguity or confusion, everything is presented in black-and-white terms. And over the last five years or so, I have had the pleasure of supporting and/or overseeing the good clinical practice (GCP) side of industry, experiencing the more “human” side of the business.

  10. Extrapolation Trials Provide Hope To Epilepsy Patients

    The concept of extrapolation has been in existence for years at the FDA. Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer of the Neurology Business Group at Eisai, is excited about the current use of extrapolation in monotherapies. The FDA approval of FYCOMPA as a monotherapy for epilepsy patients was based on data extrapolation.