COVID-19

FDA has previously made several public statements about its ability to conduct inspections and FDA personnel have also made policy comments in various public forums. Now that this guidance has...

Since the COVID-19 pandemic began in early 2020, the Center for Drug Evaluation (CDE) has maximized its capacity and optimized its regulatory procedures within the SAP framework to accelerate...

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...

With the continued threat of COVID-19, the way inspections will be performed and hosted will be significantly different from the pre-pandemic situation.

Enabling patients to participate in clinic trials from home is both important to maintain patient safety and data quality in ongoing trials and critical for many new trials as we plan for COVID-19.

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...

On June 19, 2020, FDA released a Guidance for Industry (GFI) entitled Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products...

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...

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...

Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...

Introduction/Situation COVID-19 has created a number of challenges in managing clinical trials for acute, chronic, life-threatening, and rare diseases. Due to the pandemic, as many as 90% of...

The COVID-19 pandemic has seriously impacted the US healthcare system and supportive manufacturing facilities. Some consumers and healthcare professionals are currently experiencing difficulties...

The COVID-19 global pandemic has had a significant impact on the conduct of pediatric and adult clinical drug trials. Many trials have halted enrollment, and there are multiple challenges with...