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FDA releases guidance for remotely acquiring data in clinical investigations

Healthcare IT News - Telehealth

"Compared to intermittent trial visits, the use of DHTs to remotely collect data from trial participants may allow for continuous or more frequent data collection," said FDA officials. The FDA notes that digital health tools used for remote data acquisition can offer an important role in clinical research. WHY IT MATTERS.

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Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1

Bill of Health

Food and Drug Administration or FDA), which contributes to the development of knowledge about the unapproved product’s safety. Patients seeking to use a product via EA must have a serious or life-threatening condition for which there are no comparable FDA-approved treatments or clinical trial options available.

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Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

Bill of Health

Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time. For example, the group organized a physician coalition letter where several hundred doctors called on the FDA to urgently cut the bureaucratic tape and make vaccines accessible to young children. Solutions for the Future.

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Could Self-Operated Assisted Suicide Devices Be Coming to a Town near You?

Bill of Health

FDA Approval. Food and Drug Administration (FDA), which “ regulates the sale of medical device products (including diagnostic tests) in the U.S. ” Although it is questionable whether the FDA would ever approve the Sarco machine as a medical device, it turns out the FDA may not need to. .”

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Important practice-points for pharmacists independently initiating and furnishing Paxlovid

Natalia Mazina

Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug. This form should notify patients of potential side effects, drug interactions, and other information pertaining to taking Paxlovid.

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FDA Addresses the Role of Digital Health Technology in Clinical Trials

Healthcare Law Today

Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device.

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How to Mitigate Ethical Challenges of AI-Driven Healthcare

Healthcare IT Today

The use of AI is revolutionizing the delivery of healthcare, but its use comes with significant ethical challenges that cannot be ignored, the most important of which involve bias and informed consent. . Another major ethical concern of AI use surrounds the principle of informed consent. About Natalie C. About Carly C.