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Learn MoreThe impact of COVID-19 on clinical trials in rare disease and oncology
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Learn MoreThe New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19
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...
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2:35Watch VideoRegulatory & Access: Local knowledge
Parexel’s +1000 consultants, including ~100 former regulators / HTA assessors have helped to develop guidance across the world. They not only have the global expertise but also the local know-how to h
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See Parexel's latest COVID-19 expert content
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Learn MoreMaking a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations
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...
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Learn MoreI Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19
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...
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Learn MoreAn overview of the recent Executive Order on Critical Drugs Made in America
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...
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Learn MoreThe Move Toward Global Standards: Navigating New EAEU Guidelines
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...
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Learn MoreeBook: Biopharma in the COVID-19 World
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Learn MoreNMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020
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...
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Learn MoreTop 10 Myths About Working with the FDA for an Oncology Drug Approval
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...
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Learn MoreGxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”
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...
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Learn MoreWill the FDA “CARE” More About Your Supply Chain?
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...
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Learn MoreHas EMA started a domino effect for more regulation of API manufacturing?
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...
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Learn MoreWhat’s Around the Corner for FDA Inspections?
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...
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Learn MoreFDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19
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...
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Learn MoreUsing risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19
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...
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Learn MorePutting the Pandemic in Plain Language
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...
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Learn MoreNavigating new steps in how FDA is managing COVID-19 Products
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Learn MoreUnderstanding the COVID-19 regulatory procedures the FDA is using
A diagram that shows various procedural steps when interacting with the FDA through CTAP.
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Learn MoreHow COVID-19 is Accelerating Telemedicine Adoption in Asia Pacific
About the Authors Gary Cheng is a Vice President of Health Advances and...
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