Harmonization of global regulations fosters innovation and ensures quality medicines.

Convergence in the Global Regulatory Village

Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.

Shining a Light on Junior Pharmaceuticals

QMM provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.

Introduction to Pharmaceutical QMM Model

Topic

CLiff Campbell is senior consultant at KPC.

Articles

Quality quartets support an integrated and stable combination of
commissioning and qualification and quality risk management processes.

Points to Consider for Knowledge Management Acceleration

Feliza Mirasol is the science editor for 

FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.

Acadia Pharmaceuticals Receives FDA Approval for First Treatment for Rare Genetic Disorder

FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine. 

FDA Approves Pfizer’s New Migraine Nasal Spray

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability. 

FDA Seeks $7.2 Billion to Protect and Advance Public Health

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

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Makena Saga Shows How Hard It Is to Remove Unproven Drug from Market

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Congress Probes PBM Link to Higher Drug Prices

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% 

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety. 

Harnessing Technology to Ensure Drug Safety

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Justification of Using Weight Variation Instead of Content Uniformity for Release of Relevant OSD Forms

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Quality Systems

Convergence in the Global Regulatory Village

Shining a Light on Junior Pharmaceuticals

Introduction to Pharmaceutical QMM Model