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Inspections Food and Drug Administration (FDA) Life Sciences

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Paul Hastings LLP

Post-COVID Checkup: Current FDA Due Diligence Considerations

Paul Hastings LLP on

The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Alston & Bird

Food and Drug Amendments of 2022 (PDUFA VII)

Alston & Bird on

Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do...more

Epstein Becker & Green

Unpacking Averages: Device Inspection Citations That Frequently Precede Warning Letters

Overview - In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. In this exercise, I do not try to prove causation. I am simply exploring...more

Morgan Lewis

After a Series of False Starts, FDA Resumes Domestic Inspections

Morgan Lewis on

FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more

Faegre Drinker Biddle & Reath LLP

FDA Inspection Readiness During the Pandemic

Manufacturing sites should prepare now for inspections before the U.S. Food and Drug Administration (FDA) resumes routine on-site inspections. Since 2020, FDA has delayed many routine inspections due to the pandemic. In...more

Epstein Becker & Green

Unpacking Averages: Likelihood of FDA Medical Device Inspections

It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state. Indeed, FDA includes such a map in its newly...more

Morgan Lewis - As Prescribed

Zooming in on Inspections: FDA Issues Guidance on Remote Interactive Evaluations and Roadmap on Inspectional Oversight

Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to...more

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

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....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

Inspections Remain on Hold; FDA Collaborates with CDC to Develop a Process to Resume Program

Morgan Lewis on

Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections....more

Morgan Lewis

FDA Suspends Routine Domestic Drug and Device Inspections Due to COVID-19

Morgan Lewis on

For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt...more

Morgan Lewis - As Prescribed

Uncharted Waters: Potential Regulatory Impacts of Coronavirus (COVID-19) on Pharma and Biotech Industries

With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...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

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