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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis.

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Preventing the spread of nontuberculous mycobacteria in water systems

Pharmaceutical Technology

Of these three, the highest costs for US hospitals are from NTM i nfections at $1.53bn. Identifying the biggest risks for NTM infections in hospitals All healthcare facilities should have a water safety plan to control the opportunities and conditions to prevent bacteria growing and spreading. You can’t eradicate it completely.

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

The FDA Law Blog

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance.

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How remote monitoring tech is enhancing healthcare for ageing populations

Pharmaceutical Technology

This decreases the need for hospital visits and related costs, freeing up vital time and resources for doctors and nurses to treat patients most in need. Furthermore, monitoring patients when they come out of hospital helps to avoid any relapses or readmissions, effectively providing a safety net. “A Free Whitepaper.

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Going big: How cartridges are making large-volume, high-dose subcutaneous autoinjectors a reality

Pharmaceutical Technology

For them, intravenous infusion in a hospital setting is the only option. To learn more, download the document below. model, download this white paper. However, patients with conditions requiring higher doses, such as cancer, have yet to enjoy these benefits. References 1. SHL Medical’s Molly 2.25 Autoinjector 3.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. EFPIA White Paper on CMC Development, Manufacture and Supply of Pandemic COVID-19 Therapies and Vaccines.” EMA/CHMP/BWP/187162/2018. 22 March 2018.