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The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

2003: Congress passed the Medicare Modernization Act (MMA), which included the creation of the Medicare Part D program. There was bipartisan support for the program at the hearing and support for measures such as requiring pharmaceutical companies to publish their prices in a password protected site on HRSA's website.

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CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma

ISPE

ChatGPT: “In a pharmaceutical software engineering context, data integrity refers to the accuracy, consistency, and reliability of data stored in computerized systems. This is a crucial aspect of pharmaceutical software as it directly impacts patient safety. Journal of Machine Learning Research 3 (2003): 1137–55. The Keyword.

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A New Regulatory Approach to Drive Sustainable Medicines

ISPE

A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceutical company with regard to quality. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” 27 January 2022.