2022 Dosage Pharmaceutical Manufacturing 
FDA Law Blog: Biosimilars
APRIL 16, 2024
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
European Pharmaceutical Review
SEPTEMBER 29, 2022
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.
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Quality Matters
MAY 17, 2023
Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.
Quality Matters
SEPTEMBER 15, 2023
PCM not ideal for every drug Continuous manufacturing “may not be fit for every pharmaceutical manufacturing process, but it can bring some advantages in some cases” compared with traditional batch manufacturing, summarized FDA’s Adam Fisher, Ph.D., It is not intended as a comprehensive summary or report.]
Pharmaceutical Technology
DECEMBER 6, 2022
Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. Within the small molecule landscape, several trends are shaping the industry’s future, one of the most notable being the rise of high-potency active pharmaceutical ingredients (HPAPIs).
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