News & Analysis as of

Inspections Pharmaceutical Industry Supply Chain

Hogan Lovells

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

Hogan Lovells on

On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public...more

Faegre Drinker Biddle & Reath LLP

FDA Updates Inspection Guidance with Minor Additions

The U.S. Food and Drug Administration (FDA) issued an update to its guidance document, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers,”...more

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

Arnall Golden Gregory LLP

Houston, We Have A Problem: FDA Confirms That It Will Only Conduct Mission-Critical Inspections and Prioritized Domestic...

It has been almost seven months since the Secretary of the Department of Health and Human Services (HHS) declared a public health emergency on January 31, 2020 due to the Coronavirus Disease 2019 (COVID-19).  The Food and...more

Morgan Lewis

FDA Adapts to the New Normal: Domestic Inspections Resuming Based on Tiered Risk Assessments

Morgan Lewis on

The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....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

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Hogan Lovells

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

Hogan Lovells on

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

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