Establishing a quality culture ensures a safe and effective product, and saves costs.

A Robust Quality Culture Benefits All 

Data may be used to improve (or remove) a corrective action/preventive action.

Put a Cap on CAPAs

Testing various tablet-splitting devices showed how well they performed.

Quality Management Through Process Performance

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Articles

Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA. 

Charles River Receives EMA Approval to Commercially Produce Allogeneic Cell Therapy Drug Products

The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain. 

UK Grants Marketing Authorization for Novartis’ Radioligand Therapy for Advanced Prostate Cancer 

The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.

UK Approves First Bivalent COVID-19 Booster Vaccine

Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.

Moderna and European Commission Amend COVID-19 Vaccine Agreement

Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.

FDA Approves Roche’s Influenza Treatment for Use in Young Children

Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.

FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

B.S Sathya Durga is Director at Acute Market Reports.

Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.

Modernization of India’s Pharma Manufacturing Industry: “Leader” or “Laggard”

FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines. 

FDA to Host Multi-Day Global Access Virtual Conference

FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.

FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Democrats approve curbs for Medicare plans, but not for commercial drug coverage. 

Quality Systems

A Robust Quality Culture Benefits All

Put a Cap on CAPAs

Quality Management Through Process Performance