Five points to remember if FDA issues a Form 483

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).

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...