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Inspections › Center for Drug Evaluation and Research (CDER)

Hogan Lovells

Increased use of virtual tools, optimized inspectional activities, & enhanced supply chain oversight

Hogan Lovells on

The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due to the pandemic, FDA has...more

Hogan Lovells

Five key takeaways from the Senate hearing on FDA oversight of foreign drug manufacturing

Hogan Lovells on

The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system. ...more

Akin Gump Strauss Hauer & Feld LLP

FDA Implements a New “Concept of Operations” for Drug Inspections

Akin Gump Strauss Hauer & Feld LLP on

The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more

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