Regulatory Insights

  1. FDA’s Sentinel System: Strategies For Expansion And Transformation 1/27/2020

    The FDA Sentinel System started as a congressional mandate in the FDA Amendments Act of 2007 and has given rise to one of the world’s premier evidence generation platforms. Read how this system is continuing to be invaluable and is a testbed for future projects.

  2. Success Strategies For Conducting Clinical Trials During The COVID-19 Pandemic 4/28/2021

    Our agile and scientific-minded experts have compiled a guide of critical strategies for clinical development success during the COVID-19 era. Download the guide to explore key strategies for maintaining momentum, assessing your risks, and minimizing  delays for ongoing, new, and COVID-19 related trials.

  3. Current Challenges (And Solutions) In Global Regulatory Harmonization 3/11/2020

    According to a Council of Foreign Relations report, ensuring a safe and secure healthcare marketplace that can provide innovative therapies is no longer an undertaking for a single nation. Larger harmonization agreement efforts, even with intervention by the World Health Organization (WHO), ended many times when country regulators bickered over who had the power to develop the standards and whose standards should be followed. The ICMRA, ICH, and other affiliated harmonization groups are acting to correct this.

  4. 505(B)(2) Planning: Regulatory And Study Conduct Best Practices 7/15/2020

    Watch this on-demand webinar to hear experts from Worldwide Clinical Trials and Camargo cover the latest trends and early planning recommendations for building and executing a successful 505(b)(2) development program.

  5. Botanical Medicines In Research 4/1/2020

    Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This white paper describes rationale for why IRBs should embrace botanical medicine protocols.

  6. Phlexglobal Innovation Tour 2020: Industry Survey Results & Expert Analysis 1/25/2021

    On July 15, 2020, we launched the Phlexglobal Innovation Tour to bring together experts from across our industry to discuss clinical and regulatory related topics and explore innovative approaches to making compliance faster, easier, and better. What follows are the results of focused audience polls done during each session and afterwards together with the thoughts of our Innovation Tour experts

  7. Antiviral Products In The Pre-IND Phase 8/3/2020

    Productive pre-IND interactions with FDA are important to the success of any drug development program, including infectious disease product development. This step provides opportunities for makers of infectious disease products to engage with FDA by facilitating early communications between the Division of Antivirals or the Division of Anti-Infectives within OID and sponsors/investigators of potential new therapeutics. Here, we specifically discuss antiviral products at the pre-IND stage, and unique considerations for these products.

  8. Regulatory Oversight On Gene Therapy In The U.S. And EU 10/9/2019

    Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. With the rapid evolution of the gene therapy field, regulatory agencies have been working to keep pace with these scientific and clinical breakthroughs. An understanding of the regulations and guidance documents reflecting regulator current thinking surrounding gene therapies is essential to success.

  9. Are You Ready To Begin Planning Your IND Submission? 5/4/2021

    Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product. But, are you ready? In this webinar, experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND.

  10. Global SUSAR Distribution: Lack Of Regulatory Harmony Puts Trials At Risk 5/21/2021

    The lack of global regulatory harmonization undermines safety reporting efforts, putting patients at risk and adding millions of dollars to the cost of a trial. We’ve seen at least 40 different approaches in terms of how countries handle SUSAR distribution—and it all changes regularly. It is difficult to conduct this global process correctly and the consequences of making mistakes are severe, including potential risks to patient health, regulatory repercussions, delays, or even having a trial shut down.