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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

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Top 9 Takeaways From 2232 People With Hashimoto’s

The Thyroid Pharmacist

When it leaks into the bloodstream, the body does not recognize it, and labels the structure as a foreign invader and attacks it. Accessed February 25, 2018. link] Updated March 7, 2018. Accessed March 22, 2018. link] Accessed January 15, 2018. Understanding the stress response. Harvard Health Publishing.

Immunity 111
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Twenty Women Leaders In Healthcare Industry

PharmaShots

and medical doctor in clinical pharmacology Other Affiliations: She is a member of the Board of Directors of L’Oréal S.A Award & Nominations: Fiona has been awarded with the Prize for Women in Pharmacology from Astra Zeneca issued by the British Pharmacological Society in December 2018.