News & Analysis as of September 20, 2024

Generic Drugs › Inspections

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And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on 5/11/2022

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

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

Akin Gump Strauss Hauer & Feld LLP on 9/6/2017

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

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

Arnall Golden Gregory LLP on 7/23/2015

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

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Generic Drugs › Inspections

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

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

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

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