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FDA Settles Pacira’s First Amendment Lawsuit

17 December 2015

Pacira has announced that it settled its lawsuit against FDA over the labeling and promotion of its postsurgical analgesic drug, EXPAREL®.  FDA approved EXPAREL (bupivacaine liposome...

Blog Post

Recent First Amendment Rumblings

13 May 2015

Lately, there seems to be a palpable uptick in news related to FDA’s regulation of off-label communications.  Here are some of the developments we’ve been following: In April: 

  • CDER...

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CEO Media Statements Draw Additional Scrutiny

13 May 2015

The Food and Drug Administration (FDA) has issued a second enforcement letter regarding a pharmaceutical company executive’s statements on television. On March 12, 2015, the Advertising and ...

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