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Clinical trials and pregnancy: regulators weigh in

Clarivate

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Medicine use during pregnancy: balancing risks.

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How to Work with Patient Advocates, Influencers, and Ambassadors

PM360

For example, everyone must be steeped in both FDA and FTC guidelines. Then, the MRL team and the influencer must align on where there is flexibility within messaging while still abiding to brand safety guidelines, as you don’t want to lose the authenticity that the influencer brings.

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The Future of RWE in Clinical Trial Design and Recruitment

Clarify Health

And, as you get into more specialty and rare conditions, the need from a cost, ethical, and frankly just a workflow perspective is only going to increase,” Mr. Clapsis added. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? It’s not just the FDA,” he said.

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The Future of RWE in Clinical Trial Design and Recruitment

Clarify Health

And, as you get into more specialty and rare conditions, the need from a cost, ethical, and frankly just a workflow perspective is only going to increase,” Mr. Clapsis added. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? It’s not just the FDA,” he said.

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Legal challenges put off label use of gender affirming care drugs in jeopardy

Pharmaceutical Technology

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. With restricted access and reduced prescription of puberty blockers and hormone therapies, the impact on pharmaceutical companies manufacturing these therapies also remains unclear.

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