Parexel Blog
Parexel Blog
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Learn MoreThird Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions
In the Federal Register notice, FDA reiterated that drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients.
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Learn MoreChallenges of 2020: Lessons for Clinical Trials in Diabetes
The extraordinary challenges of 2020—the global pandemic and the renewed campaign against racial injustice—have simultaneously presented opportunities for significant growth and change across the...
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Learn MoreFostering steady advances in data operations: FSP partnerships can spur and support change
When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly...
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Learn MoreThe long and winding road for quality metrics takes another turn
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).
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Learn MoreThreading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products
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...
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Learn MoreDrug Development for Rare Disease and Oncology During the COVID-19 Pandemic
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Learn MoreEarly Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting
Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the...
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Learn MoreThe Evolving Cell and Gene Therapy (CGT) Sector in China
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Learn MoreVirtual meetings are easy, right?
Recommendations for navigating the "new normal" and how to prepare for the future.
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Learn MoreOptimizing SOPS in the Digital World
For any company on the receiving end of an FDA 483 or warning letter, standard operating procedures (SOPs) represent an opportunity to simultaneously achieve compliance and improve operational...
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Learn MoreNever Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities
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Learn MoreHow Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House
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Learn MoreFive points to remember if FDA issues a Form 483
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Learn MoreThe impact of COVID-19 on clinical trials in rare disease and oncology
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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 MoreSuccessful wearable device selection for the evolving clinical trials landscape
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...
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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 MoreThe Special Approval Pathway (SAP) for COVID-19 related products in China
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...
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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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