Pharma GMP News of the Week: 12-March-2023
Period: March 05, 2023 to March 11, 2023
FDA published “Guidance for Industry: Labeling of Infant Formula”
Date of news: March 6, 2023
The Food and Drug Administration is issuing this reminder to infant formula makers and distributors (“you”) about certain infant formula labelling requirements. While this guidance explains the labelling standards for infant formula products in general, we are particularly concerned about the number of infant formula products that have the same or similar claims of identity but differ in composition or intended use. We’ve also witnessed an upsurge in the use of nutrient content claims, which constitute misbranding under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document contains information that can assist you in understanding and complying with relevant labelling regulations.
Source: Labeling of infant formula: guidance for industry
EMA published “Questions and Answers about the raw data proof-of concept pilot for industry”
Date of news: March 7, 2023
This is a guide that answers frequently asked questions about the proof-of-concept pilot for clinical studies. The pilot involves submitting and analyzing “raw data” from selected initial marketing authorization applications and post-authorization applications to the European Medicines Agency. The guide is specifically related to the “Information about the raw data proof-of-concept pilot for industry.”
Source: Questions and Answers about the raw data proof-of-concept pilot for industry
MHRA published “Fees payable to the MHRA for 2022 to 2023”
Date of news: March 8, 2023
MHRA published 39 types of Fees payable to the MHRA for 2022 to 2023.
Source: Current MHRA fees – GOV.UK
FDA published “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry”
Date of news: March 10, 2023
The FDA has created a guide for drug companies called “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.” This guide is about drugs called ARAs, like antacids, histamine H2-receptor antagonists, and proton pump inhibitors (PPIs), which are often used and can be bought without a prescription. ARAs can change the pH level in your stomach, which can affect how well other drugs work or if they are safe. It’s important to study these interactions early in drug development and share the results with doctors and patients. This guide explains when clinical studies should be done with ARAs, how to design and conduct those studies, and how to apply the results to different types of ARAs.