News and Media

Key Takeaways from FDA GCP Inspection Trends in 2021

Key Takeaways from FDA GCP Inspection Trends in 2021

The FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. The FDA’s Office of Regulatory Affairs (ORA) is the lead office for inspections and enforcement. ORA...

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How to Solve Challenges in Plain Language Summary Writing

How to Solve Challenges in Plain Language Summary Writing

Plain language summary (PLS) writers take highly technical and scientific language and translate it into common language so that it can be understood by patients and caregivers with no formal training in science or medicine. Because a PLS needs to be comprehended by...

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Avery Zimmerman

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6880 Commerce Blvd.
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