Pharmaceutical Technology

JUNE 27, 2025

June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.

Labelling 52

Labelling FDA Packaging Communication 52

ISPE

MAY 10, 2023

End-to-End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation.” 3M explores New Label-As-A-Service Concept with Blockchain on Azure to Stop Counterfeit Pharmaceuticals.” Lakerveld, B. Benyahia, P. Barton, R. Braatz, et al. 47 (18 November 2013): 12359–63. doi:10.1002/anie.201305429

Chemotherapy 52

Chemotherapy Documentation Dosage Labelling 52

ISPE

MARCH 29, 2023

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. For purpose of illustration used throughout this article, labels have been assigned to each CQA.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. For purpose of illustration used throughout this article, labels have been assigned to each CQA.

Documentation 52

Documentation Dosage Packaging Communication 52

The Checkup by Singlecare

JANUARY 15, 2024

When using Adderall off-label for depression, there are many things prescribers consider. Some providers will prescribe Adderall or another stimulant medication off-label to help some patients who are struggling to find a treatment or combination of treatments to help them manage their mental health conditions.

Mayo Clinic 105

Mayo Clinic Controlled Substances Adverse Reactions Dosage 105

ISPE

AUGUST 30, 2022

The original molecular weight (MW) specification for polypropylene glycol 2000 (PPG) of 1800–2200 was based on the Food Chemical Codex monograph (90%–110% of label) and not based on a scientific understanding of the process/product requirements. Case Study 1: Polypropylene Glycol—Removal of Noncritical Attribute from Specification.

Documentation 52

Documentation FDA Packaging Communication 52