Sorry, You Probably Cannot Get MDMA Through Telehealth
Lykos’ current application is based on MDMA-assisted therapy, and FDA will almost surely require that patients take the drug in a clinical setting.
off-label
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Read more: Thank Ketamine for the Telehealth Extension Thank Ketamine for the Telehealth Extension
The telemedicine extension is not just for psychedelics; easing these restrictions means relaxing them for other controlled substances as well.
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Read more: Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice
Can young people consent to COVID-19 vaccinations?
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Read more: Reflections on Procedural Barriers to Pediatric COVID Vaccine Access Reflections on Procedural Barriers to Pediatric COVID Vaccine Access
Bureaucratic tape is causing delays in distributing these critical vaccines to our youngest children.
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Read more: Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines
The CDC is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.
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Read more: Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited? Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?
We think that off-label pediatric administration of approved COVID-19 vaccines should be left to individual risk-benefit judgments.
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Read more: National Survey Suggests that Off-Label Status is Material to Informed Consent National Survey Suggests that Off-Label Status is Material to Informed Consent
By Christopher Robertson As many readers of this blog know, the FDA requires that, prior to entering the market, companies prove safety and efficacy for each intended use of their products, but physicians are then free to prescribe the products for any other uses. (Companies are not allowed to promote off-label uses however.) A recent national survey by…