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Psychedelic medicines: are they gaining traction in Europe?

European Pharmaceutical Review

6 Therefore, the quality of data provided to regulators will be key in obtaining MAs and subsequently marketing of psychedelic medicines. 6 Therefore, the quality of data provided to regulators will be key in obtaining MAs and subsequently marketing of psychedelic medicines.

Medicine 131
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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. 2 Approach taken by regulators in the UK The Medicines and Healthcare products Regulatory Agency regulates herbal medicines in the UK. 2012/1916). 2012/1916). 2012/1916).

Marketing 103
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Tapping into digital therapeutics to improve neurological outcomes

Pharmaceutical Technology

Companies are testing the use of digital platforms along with pharmacological treatments. But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging. Digital therapeutics can be also categorised based on their regulatory journey.

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Cala® Launches The Cala kIQ™ System, Offering Meaningful Tremor Relief for Patients With Essential Tremor and Now Parkinson’s Disease

Legacy MEDSearch

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

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How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels

PM360

Typically, a drug label refers to any information provided with prescription drugs, as requested by regulators such as the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

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Pharma Injecting Life into Digital Health Amidst Funding Downturn

MedCity News

While not a panacea, these technologies can be part of a comprehensive set of solutions that help close the gap of inequity in medicine and drug development.

Pharma 112
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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. This knowledge can include pharmacology, therapeutic areas, and data from clinical trials with different medications.

Sales 52