AbbVie files an NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, indicated for managing endometrio...
Stakeholders praise FDA for enforcement discretion for manufacturers to meet Drug Supply Chain Security Act product identifier requirements.
FDA recommends patients not take Kayexalate and other oral medicines at the same time to prevent reducing the effectiveness of the other medicines.
PharMEDium Services recalls all unexpired lots of oxytocin compounded with lactated ringers and all unexpired lots of oxytocin compounded with lactate...
FDA clears an OmniLife Science 510(k) for its proprietary robotic tissue balancing device for use with the companys OmniBotics robotic-assisted total ...
Six health groups ask FDA to remove ultra-high dosage unit opioid analgesics from the market because their harms outweigh the benefit of taking fewer ...
FDA publishes a guidance listing items to consider when developing and designing interoperable medical devices.
Federal Register notice: FDA makes available a draft guidance on Providing Regulatory Submissions in Electronic Format Content of the Risk Evaluation...