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Food and Drug Administration (FDA) Regulatory Requirements Health & Safety Standard

Goodwin

US Emerging as Top Global Medtech Destination

Goodwin on

For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more

Searcy Denney Scarola Barnhart & Shipley

The Role of the FDA in Regulating Eye Drops to Prevent Contamination

Contaminated eye drops present serious risks. Not only can they cause blindness and other serious medical conditions, but they have also been linked to at least four cases of premature death caused by severe bacterial...more

Hogan Lovells

COVID-19 Update: FDA Issues Guidance for Food and Agriculture Sector Businesses on the Use of Masks and What to Do if a Worker is...

Hogan Lovells on

This post summarizes two recent documents the U.S. Food and Drug Administration (FDA) issued for the Food and Agriculture Sector in response to the COVID-19 outbreak. The first, “Use of Respirators, Facemasks, and Cloth Face...more

Hogan Lovells

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more

Hogan Lovells

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

Hogan Lovells on

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first...more

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