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Pregnant women in clinical trials: FDA questions how to include them
Lack of research can be harmful to mother and fetus, FDA draft guidance says, and it can be “ethically justifiable” to include them in studies.
FDA/CDC
FDA recalls kratom products for salmonella contamination
Agency issues its first-ever mandatory recall of the controversial herbal product.
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FDA advisors recommend lofexidine for opioid withdrawal
SILVER SPRING, MD. – A nonopioid agent for symptomatic treatment of opioid withdrawal could be another option to address the opioid epidemic.
FDA/CDC
FDA wants data on role of flavored tobacco products in youth initiation
“Youth consistently report product flavoring as a leading reason for using tobacco products,” FDA Commissioner Gottlieb noted.
FDA/CDC
Lurasidone approved for bipolar I depression for children aged 10-17
The approval is based on results of a 6-week, randomized phase 3 study of 347 children and adolescents.
FDA/CDC
Opioid deaths in the ED increase nationally
Opioid overdose deaths have reached an all-time high across the country.
FDA/CDC
New buprenorphine formulation approved for medication-assisted treatment
Patients who are currently taking other buprenorphine formulations can be transitioned.
FDA/CDC
FDA clears first-ever neurostimulation device for opioid withdrawal symptoms
In one study, almost 90% of patients transitioned to medication-assisted treatment after 5 days of using the device.
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Adherence boon, or Big Brother loom?
Take our poll on the first drug approved in the United States with a digital ingestion tracking system.
FDA/CDC
FDA approves cariprazine for schizophrenia maintenance treatment
Approval is based on results of a 72-week double-blind, randomized study of three daily doses of the antipsychotic, compared with placebo.
FDA/CDC
FDA panels support two NDAs for buprenorphine subcutaneous injections
The panelists agree that subcutaneous formulations might help step the opioid epidemic.