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Dr. Scott Gottlieb, Former Commissioner of the Food and Drug Administration speaks with Parexel’s Peyton Howell, Executive Vice President, Chief Commercial & Strategy Officer and Sy Pretorius, Executi

RWE experts Leanne Larson, Senior Vice President and Worldwide Head, Real-World Evidence and Access and Amy McKee, Vice President, Regulatory and Access dig deeper into the evolving role of RWE.

Once the full fury of the pandemic was understood, the Food and Drug Administration turned to a number of tools that already existed to help fill the gap for information that was normally...

In the Federal Register notice, FDA reiterated that drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients.

In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

Parexel has a heartfelt conversation with Lennie & Denny Woods, Parents & Co-Founders of Sara’s Cure (https://sarascure.org/), of their daily fight to find a cure for Clear Cell Sarcoma.

This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...

Recommendations for navigating the "new normal" and how to prepare for the future.


About the Authors Mansi Shinde, Ph.D. is an Engagement Manager based in the...

About the Authors Daniel Huang is an Analyst based in the Hong Kong...

Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief...

Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...