Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

Labelling 62

Labelling Biosimilars Adverse Reactions Dosage 62

The Thyroid Pharmacist

DECEMBER 28, 2022

Knowing there were others who also had thyroid conditions, and wanting to spread the message, I decided to summarize my research and improvements in my book, Hashimoto’s: The Root Cause, in 2013. When it leaks into the bloodstream, the body does not recognize it, and labels the structure as a foreign invader and attacks it.

Immunity 111

Immunity Immunization Clinical Pharmacology Doctor of Pharmacy 111

PharmaShots

MARCH 9, 2023

and medical doctor in clinical pharmacology Other Affiliations: She is a member of the Board of Directors of L’Oréal S.A and Banco Bilbao Vizcaya Argentaria S.A LinkedIn Total experience: 16 yrs. Present company and time period: Johnson & Johnson (13 yrs. LinkedIn Total experience: 37 yrs.

Clinical Pharmacology 40

Clinical Pharmacology Immunization Immunity Pharmaceutical Companies 40