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

Perkins Coie

FDA and USDA Seek Comments on Standardizing Food Date Labeling

Perkins Coie on

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) recently published a joint Request for Information (RFI) seeking stakeholder input related...more

Searcy Denney Scarola Barnhart & Shipley

Understanding the Manufacturing Process of Eye Drops and How Contamination Can Occur

Searcy Denney Scarola Barnhart & Shipley on

The U.S. Food and Drug Administration (FDA) has recently identified several brands of eye drops that were sold with contaminants. These contaminants—which were introduced into the affected eye drops during the manufacturing...more

King & Spalding

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

King & Spalding on

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with...more

Foley Hoag LLP

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

Foley Hoag LLP on

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

Hogan Lovells

The FDA now offers cGMP Declarations

Hogan Lovells on

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more

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