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Harmonization of global regulations fosters innovation and ensures quality medicines.
Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.
QMM provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.
March 15, 2023
Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.
March 14, 2023
FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.
FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine.
FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.
March 10, 2023
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.
March 09, 2023
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.
March 06, 2023
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.
March 03, 2023
The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.
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.
Lipids aren’t the only important ingredients influencing stability and in vivo performance.