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The FDA worked with Baxter to help restore production as the previously existing shortages of IV saline and amino acids for injections had been exacerbated when Hurricane Maria struck. Read More
Sponsors of medical devices should submit a declaration of conformity, certifying compliance with the standards on a list maintained by CDRH. Read More
The company is required to make clinical trial data relating to Infuse publicly available through the government-run website ClinicalTrials.gov. Read More
Devicemaker giant Medtronic has agreed to a $2.4 million settlement in a case at Massachusetts’ Suffolk Superior Court over claims about deceptively marketing its Infuse Bone Graft. Read More
The FDA is now monitoring about 90 medical products, including devices, biologics, and drugs, that are manufactured in Puerto Rico and are critical to patient health. Read More
The FDA continues to grapple with shortages of saline intravenous injection bags that were worsened when Hurricane Maria devastated Puerto Rico, and the agency is temporarily allowing the importation of bags to boost the supply, Commissioner Scott Gottlieb said. Read More