FDA clears a Profound Medical 510(k) for the companys Thermal Boost module for use in conjunction with its Tulsa-Pro, which permits surgeons to ablate...
FDA clears an Exactech 510(k) for its Activit-E polyethylene for the Vantage Total Ankle System.
VistaPharm (Largo, FL) recalls one lot of sucralfate oral suspension due to Bacillus cereus contamination.
FDA issues Coherus BioSciences a complete response letter on its BLA supplement for Udenyca Onbody, the companys on-body injector presentation of Uden...
After suffering severe tornado damage at its Rocky Mount, NC plant, Pfizer says it has now restarted most manufacturing lines.
FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisks Clayton, NC facility during a 7/6-13 inspection.
It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to approve an appropriatio...
Federal Register notice: FDA makes available a draft guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.
