Latest Developments and Insights

Project Orbis: Accelerating Global Access to Innovative Cancer Therapies
Authorized by the 21st Century Cures Act , Food and Drug Administration’s (FDA) Oncology Center for Excellence (OCE) was established in January 2017. OCE was established to facilitate the development and clinical review of oncology products by uniting scientific experts…
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The Importance of Quality in Drug Development with Insights from the FDA Fiscal Year 2023 Report on the State of Pharmaceutical Quality
Overview In the intricate world of drug development, the role of quality cannot be overstated. Ensuring the safety, efficacy, and reliability of pharmaceuticals is a cornerstone of the healthcare industry, as highlighted in the U.S. FDA’s Fiscal Year 2023 Report…
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Why are Biologics Drugs Different
What is a biologic drug and how does it differ from a traditional small molecule drug? Biologic drugs have increasingly provided for broader therapeutic use over the last few decades and this trend is accelerating. The debate surrounding biologics vs…
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Why Hire an Experienced CMC Consultant for Your Early Phase Studies
The simple answer is you save money, time and get an exciting new drug to the clinic for patients. What is Regulatory CMC and why do I need to pay attention to this during development? Regulatory CMC is at the…
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The Next Generation of Regulatory Submissions: Exploring the Benefits of eCTD 4.0
The eCTD (electronic Common Technical Document) is the standard format the pharmaceutical industry uses to submit regulatory information to agencies worldwide. For the last 20 years, the eCTD has provided the structure to facilitate the review of pharmaceutical products through…
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Understanding the Nuances of a Clinical Study Protocol
One of the first recommendations that I received as an entry-level medical writer when I started writing clinical study protocols (or simply called protocols) was “not all protocols are created equally”. This may seem obvious, but as I gained more…