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Shutdown Delays FDA Peanut Allergy Drug Review

Closed sign

Regulatory review of a drug to prevent allergic reactions to peanuts appears to be delayed by the shutdown of some U.S. government operations. . . . → Read More: Shutdown Delays FDA Peanut Allergy Drug Review

AI, Wearables Posing Health Privacy Risks

Operating a smart watch

An analysis shows artificial intelligence algorithms can connect Americans’ activity tracking data to to their individual private medical information. . . . → Read More: AI, Wearables Posing Health Privacy Risks

Duchenne Stem Cell Trial Halted

Stop signs graphic

A clinical trial testing stem cell treatments for symptoms of Duchenne muscular dystrophy is on hold after a patient reported a severe reaction. . . . → Read More: Duchenne Stem Cell Trial Halted

Govt. Shutdown Disrupts U.S. Science

U.S. Capitol

Several agencies that run or finance labs are closed, due to the lapse of funding for about a quarter of federal departments that began on 22 December. . . . → Read More: Govt. Shutdown Disrupts U.S. Science

FDA Clears Inhaled Parkinson’s Drug

Brain circuits

A drug administered as an inhaled powder to supplement a common treatment for Parkinson’s disease received approval for marketing from the Food and Drug Administration. . . . → Read More: FDA Clears Inhaled Parkinson’s Drug

CDC Finds 12 People Sickened by Stem Cell Provider

Blood sample tubes

Centers for Disease Control and Prevention issued a report on a provider of stem cell therapies indicating 12 people in 3 states were infected with bacteria from that company’s treatments. . . . → Read More: CDC Finds 12 People Sickened by Stem Cell Provider

FDA Warns Cord Blood-Stem Cell Company

E. coli bacteria

Food and Drug Administration recently warned GeneTech Inc. that its unauthorized stem cell regenerative medicine products, may be causing serious blood infections. . . . → Read More: FDA Warns Cord Blood-Stem Cell Company

Analysis – Health Care Law Ruled Unconstitutional

Supreme Court

Adler and Gluck call the action, “a shocking legal ruling.” In addition, the authors characterize the decision as, “an exercise of raw judicial power.” . . . → Read More: Analysis – Health Care Law Ruled Unconstitutional

Validation Scheme Proposed for Medical Algorithms

Biocircuits illustration

A law school professor urges developers, users, and regulators of machine learning in medicine to validate the algorithms that represent their underlying decision-making processes. . . . → Read More: Validation Scheme Proposed for Medical Algorithms

FDA Clears Mobile App for Opioid Use Disorder

Man with smartphone

The Food and Drug Administration authorized a mobile app, when prescribed by clinicians for patients with opioid use disorder in outpatient treatment programs. . . . → Read More: FDA Clears Mobile App for Opioid Use Disorder