FDA Law Blog: Biosimilars

APRIL 7, 2025

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Further, information presented on the adverse reaction data was inconsistent with the PI.

Vaccines 65

Vaccines Adverse Reactions 65

RX Note

FEBRUARY 23, 2023

Drug-Food Interactions - Predominantly the effect of food on absorption Drugs and Pregnancy - Discussing FDA Pregnancy and Lactation Final Rule and Australian Categories for Prescribing Medicines in Pregnancy Drugs and Lactation - Discussing key references Dosing in Obese - One dose fits all?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

The Thyroid Pharmacist

NOVEMBER 8, 2024

I started speaking about the connection our stool testing showed between Blasto and Hashimoto’s in 2014, wrote a comprehensive blog about it in 2015, and shared my findings with my Thyroid Mastermind colleagues. A 2014 study found that almost 25 percent of people with chronic hives also had Hashimoto’s. Published 2014 May 15; Inrae.

Immunization 81

Immunization Immunity Diabetes Adverse Reactions 81