March 28, 2017

Commissioner Califf's "Going Away" Presents: FDA Final Rule & Draft Guidances to Transform Product Communications


The Florham Park office hosted BioNJ’s annual Legal, Compliance, and Regulatory Forum, titled “Commissioner Califf's 'Going Away' Presents: FDA Final Rule & Draft Guidances to Transform Product Communications” on March 28, 2017.

In the waning days of the Obama Administration, the FDA issued several historic documents that transform how pharmaceutical, biologic and medical device companies communicate about their products. These updates include two draft guidances, a First Amendment memo, and the Final Rule on "Intended Use." In-house attorneys and commercial and compliance representatives from pharmaceutical, medical device, and biotech companies attended the event, which was an open discussion of the impact of the new rules and guidances on the life sciences industry. Mike Zogby, a products liability partner and member of the firm’s Pharma and Life Sciences Industry Group, helped to organize the event.

BioNJ Legal, Compliance, and Regulatory Forum

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