Parexel Blog

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...

On August 6, 2020 the president of the United States signed an Executive Order (EO) on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. The...

There are a plethora of different devices available, ranging from commercially available actigraphy to specialized and medically approved devices. This article is designed to help sponsors...

As the pandemic clearly revealed, there is an urgent need for a more cohesive, coordinated approach to streamline global regulatory guidelines to ensure patients have faster access to new and...

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...

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...

Decentralized clinical trials (DCT) had already begun to gain momentum, and the pandemic has dramatically accelerated their adoption. Enabling patients to participate in clinic trials from home is...

The functional service provider (FSP) outsourcing model enables sponsors to efficiently and cost-effectively manage workforce needs across clinical portfolios. FSP models proved to be a strategic...

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...

Chances are, you are reading this article in your home office, or perhaps in a corner of the dining room – but probably not in your normal workspace. Just as most of us have had to adjust to...

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...

Amidst the human tragedy of the current pandemic, clinical trials must go on as sponsors strive to develop and deliver life-saving treatments. While the impact of the pandemic on clinical trials...