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FDA Issues Draft Guidance for Biosimilar Products Labeling

The FDA has announced the availability of a draft guidance for industry entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.”

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Morten Nilsson: More options are needed in order to deliver consolidation

Morten Nilsson looks at the outlook for pension market consolidation.

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To List Or Not To List; That Is The Question – The FTC Signals The Potential For Greater Scrutiny Of Patent Information Submissions To FDA - Food and Drugs Law

Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny.

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FDA ends interchangeability statement requirement for biosimilar labels

The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar…

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FDA Releases Draft Labeling Guidance For Biosimilar Products - Life Sciences, Biotechnology & Nanotechnology

Last week, FDA released a draft guidance, "Labeling for Biosimilar and Interchangeable Biosimilar Products" ("2023 Draft Guidance") that—when finalized—will revise and replace its July 2018.

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