Remove FDA Remove Pharmacology Remove Prescription
article thumbnail

Swing’s digital therapy for fibromyalgia hits the right beat

pharmaphorum

Non-pharmacological interventions like CBT are generally recommended as first-line treatment for fibromyalgia, a complex disorder with no known cause, but these are usually delivered by a therapist – often in short supply in health systems around the world. It is available on prescription from healthcare providers.

article thumbnail

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

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

Marketing 103
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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.

article thumbnail

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). International sources: The focus for many labeling teams is on major sources such as FDA and EMA.

article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. What will the future hold for clinical research?

article thumbnail

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.

article thumbnail

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Medgadget

While for other patients the possible adverse side effects from medication may prevent them from finding pharmacological therapies effective. The product will be available in the US this year as a prescription device, designed to fit into any clinic, administered under the direction of mental healthcare professionals.