News & Analysis as of

Regulatory Oversight Clinical Trials Supply Chain

Morgan Lewis

Key Considerations for Foreign Clinical Trials When Looking Abroad for Product Development

Morgan Lewis on

With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Hogan Lovells

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

Hogan Lovells on

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more

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