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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in API ingredients manufacturing.
Establishing a quality culture ensures a safe and effective product, and saves costs.
Data may be used to improve (or remove) a corrective action/preventive action.
November 28, 2022
High-cost-per-dose large molecules can make a big impact on cell and gene therapy supply chain management.
CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.
The complete online database of ACS Reagent Chemicals is now available.
November 21, 2022
Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.
Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.
Element has opened a new 7500-ft3 facility that will be used to evaluate aerosolized product efficacy for reducing airborne organisms and viral particles.
November 10, 2022
The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.
November 09, 2022
The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.
The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.
November 04, 2022
This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.