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Healthcare › FDA Approval › Enforcement Actions

Cozen O'Connor

Connecticut Loses It with Companies Selling “Research Grade” GLP-1 Drugs

Cozen O'Connor on

Connecticut AG William Tong announced enforcement actions against companies that allegedly advertised, distributed, or sold so-called “research grade” versions of GLP-1 weight loss drugs in violation of state consumer...more

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

Knobbe Martens on

The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

Arnall Golden Gregory LLP on

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Mintz - Health Care Viewpoints

FDA Expands Face Mask Enforcement Policy to Allow Imports of KN95 Respirators

Mintz - Health Care Viewpoints on

On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more

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