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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 20, 2023
How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.
March 16, 2023
27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.
March 15, 2023
Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.
A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.
Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.
By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.
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.