Remove 2024 Remove Ethics Remove Food and Drug Administration
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Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?

European Pharmaceutical Review

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults.

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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Some countries have blocked parallel trade to prevent supplies from depleting.

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The Role of Certified Pharmaceutical Representatives in the Shifting Sales Landscape

Pharmaceutical Representative Training

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Ethical Conduct: In pharma sales, ethical conduct and behavior is crucial.

Sales 52
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THEPM360TRAILBLAZER AWARD WINNER – Lifetime Achievement Award – Adam Schechter, CEO and Chairman, Labcorp

PM360

Winning a Lifetime Achievement Award after 40+ Years of Leadership Labcorp’s Adam Schechter was presented a Lifetime Achievement Award at the 2024 Trailblazer Awards, which took place at Gotham Hall in New York City, October 1. Adam is an ethical leader who leads his business to serve the needs of patients and advance healthcare globally.

Ethics 59
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Microscopic Markets with Macroscopic ImpactCrafting personalized campaigns for small patient populations.

PM360

This is partly due to the limited market potential for drugs in the space, but also due to the sheer volume of rare diseases: approximately 6,000–8,000 have been identified. The overarching theme: As with rare disease drug development, precision and personalization are key. Food & Drug Administration (FDA).

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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

HHS DSI Presentation (1/18/2024) Specifically, the HTI-1 Final Rule establishes algorithm transparency and risk management requirements and introduces the agency’s “FAVES” principles. Appropriate: Guarantees that DSIs are suitable for the contexts and populations in which they are used, adhering to relevant clinical and ethical standards.

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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

HHS DSI Presentation (1/18/2024) Specifically, the HTI-1 Final Rule establishes algorithm transparency and risk management requirements and introduces the agency’s “FAVES” principles. Appropriate: Guarantees that DSIs are suitable for the contexts and populations in which they are used, adhering to relevant clinical and ethical standards.