News & Analysis as of

Filing Requirements Biotechnology

Bergeson & Campbell, P.C.

APHIS Announces Updated Pre-Application Questionnaire in APHIS eFile

On June 13, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that its Biotechnology Regulatory Services (BRS) has launched an updated Pre-Application Questionnaire...more

Paul Hastings LLP

President Biden Executive Order Signal to Industry of CFIUS’s Importance, Without Process Changes

Paul Hastings LLP on

On September 15, 2022, President Biden issued an Executive Order regarding the Committee on Foreign Investment in the United States (“CFIUS” or the “Committee”)....more

Vinson & Elkins LLP

BIS Expands Export Controls over Biotechnology Software with Implications for CFIUS Mandatory Filing Requirements

Vinson & Elkins LLP on

On October 5, 2021, the Bureau of Industry and Security (“BIS”) issued a final rule formally expanding its controls over the export of biotechnology software. ...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: CFIUS reporting obligations

Hogan Lovells on

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

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