Patient engagement: Being heard

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.

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...

Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...

On March 27, 2020 the president of the United States signed into law the Coronavirus Aid, Relief and Economic Security (CARES) Act in response to the emerging pandemic (a copy of the public law...

On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence of N-nitrosamine impurities in angiotensin II receptor blocker drugs. You can find a...

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...