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Pharmaceutical Industry › Filing Requirements

Hogan Lovells

First company receives FDA violation notice for ClinicalTrials.gov submission omission

Hogan Lovells on

On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. In...more

Morgan Lewis

Overview of Medical Device Regulation in China

Morgan Lewis on

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...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

Foley & Lardner LLP

District Court Upholds FTC Hart-Scott-Rodino Rules for Pharmaceutical Patent Transfers

Foley & Lardner LLP on

A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We...more

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