News & Analysis as of

Supply Chain Inspections

Braumiller Law Group, PLLC

[Webinar] Agricultural Cargo Security Is In Your Hands - January 24th, 9:30 am - 10:30 am CST

In this one-hour training, you'll learn how to exercise the power you have to help secure our nation's supply chain across all modes of transportation and types of cargo. Even those not participating in the CTPAT program need...more

Husch Blackwell LLP

A Legislative Session In Review: Taking A Look At Key Energy Bills That Did (And Did Not) Pass During The 87th Regular Session

Husch Blackwell LLP on

After Winter Storm Uri devastated the ERCOT grid, calls for industry reform rang out across the state of Texas. For the past few months, public hearings and floor debates have considered wide-ranging proposals to harden the...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

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

Husch Blackwell LLP

FDA Provides Updated Plan On Inspections During COVID-19

Husch Blackwell LLP on

The U.S. Food and Drug Administration (FDA) announced updated plans for conducting routine inspections of domestic and foreign inspections during the COVID-19 public health emergency. In March, FDA announced that it was...more

Hogan Lovells

COVID-19 Update: FDA Announces Plans to Conduct Remote FSVP Inspections

Hogan Lovells on

In response to the COVID-19 outbreak, the U.S. Food and Drug Administration (FDA) has announced it will begin requesting that importers send the agency records required under the Foreign Supplier Verification Programs (FSVP)...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

Holland & Knight LLP

Delaware Master Recommends Dismissing Books and Records Request by Activist Shareholder

Holland & Knight LLP on

On August 16, 2013, a master in chancery issued a draft report recommending that the Delaware Chancery Court dismiss a request by an activist stockholder to inspect the books and records of a large corporation that produces...more

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