An opportunity in a time of crisis: COVID-19 and the new pragmatism

About the Authors Aaron Dy, Ph.D. is a Senior Analyst in the Health Advances...

On August 19, FDA published the final guidance Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. You can find...

About the Authors Steven Chang, Ph.D. is a Senior Analyst in the Health...

The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005.  SAP is...

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...

Key Takeaways The COVID-19 pandemic has drawn attention to international efforts to promote...

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...

Click here to download the full presentation. SummaryAs the world continues to battle...

There have been two recent activities from the U.S. Food and Drug Administration (FDA) that provide industry more insight into how the agency is approaching product and manufacturing quality...

Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices.  Numerous...

During the COVID-19 pandemic, challenges to the conduct of clinical trials may arise, e.g. due to travel restrictions or quarantines, interruptions to supply chains, or when site personnel or...

The COVID-19 pandemic has brought many negative feelings to the forefront of our everyday lives, including anxiety, fear and social division, but what if we explored the new positive relationships...

About the Authors Saakshi Chadha, PhD is a Senior Analyst in the Health...

On April 21, 2020, a proposed piece of legislation was introduced in the U.S. House of Representatives. The proposed bill is titled “COVID-19 Every Worker Protection Act of 2020” and is identified...

As the entire healthcare ecosystem grapples with the COVID-19 virus, more evidence surfaces every day of manifestations beyond fever, respiratory symptoms and fatigue. In fact, a recent...