News & Analysis as of

Regulatory Requirements › Investment › Food and Drug Administration (FDA)

J.S. Held

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

J.S. Held on

To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more

Hogan Lovells

Reshoring EO aims to streamline permitting, approval, and oversight of US drug manufacturing

Hogan Lovells on

On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Medical Device and Technology

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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