The NEST Collaborating Community issues a draft playbook on using medical device unique device identifiers at the point of care.
GSK says a Phase 2a study showed that GSK3036656, an investigational antitubercular agent, was well tolerated and showed early bactericidal activity w...
FDA approves an expanded use for GE Healthcares DaTscan (ioflupane I 123 injection) for use in patients with suspected dementia with Lewy Bodies.
FDA issues a five-item Form FDA-483 after conducting a pre-approval inspection of Lupins Nagpur, India Unit-2 injectable manufacturing facility 10-17-...
Some 165 healthcare-related organizations urge Congress to pass the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act before the ...
FDA says MITRE has updated a 2018 playbook explaining how healthcare organizations can prepare for and respond to cybersecurity incidents.
FDA is soliciting comments on a preliminary assessment that some naloxone products may be safe and effective when sold over-the-counter.
FDA medical reviewers ask the Cardiovascular and Renal Drugs Advisory Committee to consider whether the benefits of Ardelyx tenapanor outweigh its ris...
