Featured Editorial

91. FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics 10/20/2022

    The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.

92. Will DCTs Become The Norm? 10/5/2022

    Decentralized clinical trials (DCTs) have been an option for more than a decade, though the pandemic has been the catalyst for change. There is no doubt that DCTs and digitalization are starting to transform clinical research, but will they become the norm?

93. Life Sciences RIM: Modernization & Moving Ahead 9/28/2022

    Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.

94. How To Take Full Advantage Of RWD Without Jeopardizing Privacy Laws 9/26/2022

    Biopharma companies need personally identifiable information to aggregate and analyze valuable real-world data. However, in many countries, these details are protected by data privacy laws. The EU's EHDS regulation helps clarify the situation in Europe, but other regulatory authorities will also need to clarify and articulate their positions.

95. Using RWE In Clinical Trials: Challenges & Opportunities 9/19/2022

    What are real-world data (RWD) and real-world evidence (RWE), and how can we overcome the challenges of integrating them into clinical trials to produce better outcomes?

96. EU Reg. 536/2014's Expiry Label Requirement Forces Us Backward, Not Forward 9/14/2022

    In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.

97. Walgreens Is Ready To Re-Envision Recruitment, DCTs, And RWE 9/12/2022

    Since becoming CEO of Walgreens Boots Alliance (WBA) in March 2021, Rosalind Brewer has been focused on healthcare and what the company could do to help its patients. WBA refers to the integrated healthcare, pharmacy, and retail store that currently serves millions of customers and patients every day. This past June, the company launched its clinical trial business. 

98. Digital Solutions, Technology, And Patient Care Top Life Science Trends 9/6/2022

    Technology company Within3 has produced a paper on the six top trends that are going to impact the pharmaceutical space. It’s no surprise that technology solutions were one of the trends making the list, but also included were factors such as patients, cyber threats, and a growing global marketplace.

99. Combining Data Science & RWE For Better Clinical Outcomes For Immunological Diseases 8/15/2022

    As we continue to better understand immune-mediated inflammatory diseases, Janssen is applying machine learning and artificial intelligence to real-world data to generate real-world evidence (RWE). This RWE gives us a deeper awareness of patient needs, gaps in current treatment options, and a vision toward new areas of research. 

100. Pharma Companies Are Tapping Digital Health For Improved Patient Outcomes 8/11/2022

     Smarter diagnostic tools and a growing role for remote care will be of huge importance in the new paradigm. The pharma industry, which is already growing its role in delivering hybrid solutions combining therapies with diagnostic and smart solutions and devices, could play a significant role here.