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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 pharmaceuticalmanufacturing site quality rating system, the Quality management maturity (QMM) programme.
Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. Clarify launched its real-world evidence on health disparities in 2021.
In the US, members of the public can request, through a Citizen Petition, that the US Food and Drug Administration (FDA) “take or refrain from taking” various administrative actions, including denying approval of generic and biosimilar drug applications.
The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines. Defossilization of pharmaceuticalmanufacturing. Mapping Global Flows of Chemicals: From Fossil Fuel Feedstocks to Chemical Products. 33, February 2022, 100586.
Over the past few years nitrosamines and nitrosamine impurities have been increasingly gaining the reputation of being high-risk containments in the food industry. The food sector has already initiated the publication of preliminary regulations aimed at restricting PFAS in packaging. [3].
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