Quality Systems

Feliza Mirasol is the science editor for 

Articles

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

Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.

Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone 

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% 

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle. 

FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins

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.

Regulatory Oversight and Compliance