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Getting ahead of regulatory changes around PFAS in pharmaceutical packaging

Clarivate

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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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

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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Diversity and inclusion in oncology clinical trials

Clarify Health

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. In fact, 73% were White, 14% were Asian, 6% were Hispanic, and 5% were African American.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

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. Conclusion. 5260 (“Reduced Costs and Continued Cures Act”), [link].

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines. Delivering cellular and gene therapies to patients: solutions for realizing the potential of the next generation of medicine. Green Chemistry in the Synthesis of Pharmaceuticals.