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New ethical guidance for paediatric clinical trials

European Pharmaceutical Review

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials. Thus, numerous drugs and medical devices approved and licensed by the FDA are missing essential paediatric-specific information on their product labels.

Ethics 98
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Which Social Media Analytics Matter Most in Pharma Marketing

Pharma Marketing Network

Compliance and Ethical Considerations in Social Media Analytics Pharma marketing teams must balance data-driven strategies with regulatory compliance. Social media analytics should always align with FDA, HIPAA, and GDPR regulations to protect patient privacy and ensure ethical marketing practices.

Media 52
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Ensuring Ethical Practices in Light of Potential Misuse

PharmExec

In this part of his Pharmaceutical Executive video interview, Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, talks about what steps companies developing weight-loss medications should take to ensure responsible and ethical practices.

Ethics 52
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Biogen is in deep trouble and may not survive

World of DTC Marketing

Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. As soon as the FDA gave Aduhelm approval, investors rushed to buy Biogen’s stock, and the executive was spreading Kool-aid about the product’s efficacy. Biogen’s reputation may be damaged beyond repair.

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Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Lykos cuts team by 75%, vows to keep MDMA program despite FDA veto

Pharmaceutical Technology

The FDA rejected the therapy after the AdCom raised efficacy and ethical concerns in Lykos’ trials of its lead pipeline drug.

Ethics 52
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How to integrate AI in Pharma Marketing

Pharma Marketing Network

FDA guidelines on AI-generated content. Ethical AI principles for fair and unbiased marketing. AI-driven ad targeting with ethical marketing considerations. Can AI help with FDA compliance in pharma marketing? Integrating AI with Legacy Systems Many pharma companies still rely on older CRM and data systems.