Amy Speros

Amy Speros

Latham & Watkins LLP

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FDA Issues Final Rule on Abbreviated New Drug and 505(b)(2) Applications

New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016. On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more

10/10/2016 - ANDA FDA FDA Approval FDCA Orange Book Pharmaceutical Patents

Amarin Settles Off-Label Promotion Case Against the FDA

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

3/14/2016 - Amarin Caronia FDA First Amendment Misbranding Off-Label Promotion Pharmaceutical Industry Preliminary Injunctions Settlement

A Look at the FDA’s New Social Media Guidance

Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age. On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing...more

2/14/2014 - Advertising FDA Pharmaceutical Industry Social Media

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