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Inspections Foreign Manufacturers

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

BakerHostetler

FDA Current Good Manufacturing Practice Inspections During the COVID-19 Pandemic

BakerHostetler on

In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients are involved in the potentially life-saving development of...more

Sheppard Mullin Richter & Hampton LLP

FDA Postpones Ex-US Facility Inspections

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak. Manufacturers, including contract...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Warning Letter for Refusal to Permit Inspection: Important Takeaways for Startups and Drug and Device Manufacturers

Introduction: CGMPs and FDA Inspections - Current Good Manufacturing Practices (CGMPs) are mandated by regulations enforced by the U.S. Food and Drug Administration (FDA), and must be implemented and followed by...more

Hogan Lovells

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

Arnall Golden Gregory LLP

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

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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