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Labeling Sandoz

Goodwin

FDA Issues Interim Response to UAW’s Citizen Petition on Biosimilar Labeling

Goodwin on

As we previously reported, UAW Retiree Medical Benefits Trust and affiliated funds filed a Citizen Petition on November 2, 2015 asking FDA to adopt a “same labeling” approach for biosimilar labeling. On May 19, 2016, FDA...more

K&L Gates LLP

The Name Game: Institutional Investors Submit Citizen Petition Regarding Biosimilar Labeling

K&L Gates LLP on

On November 23, 2015, a group of fifteen institutional investors submitted a citizen petition to the FDA regarding biosimilar labeling (“Investors’ Citizen Petition”). The group includes investors from the public sector and...more

Patterson Belknap Webb & Tyler LLP

FDA Approach to Labeling Treats Biosimilars Like Generics

One of the FDA’s recent biosimilar guidance documents has drawn criticism for eliminating labeling information necessary for physicians to make prescribing decisions. The guidance document, titled, “Scientific Considerations...more

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