FDA warns Chelmsford, ME-based Zoll Medical about Quality System and Medical Device Reporting violations in its manufacturing of several medical devices.
A 6/18 advisory committee meeting is set to review Moderna's investigational mRNA influenza vaccine as the agency posts a briefing document revealing a more favorable outlook than many observers expected after a February Refusal-to-File letter was issued on the BLA.
FDA warns Chelmsford, ME-based Zoll Medical about Quality System and Medical Device Reporting violations in its manufacturing of several medical devices.
A 6/18 advisory committee meeting is set to review Moderna's investigational mRNA influenza vaccine as the agency posts a briefing document revealing a more favorable outlook than many observers expected after a February Refusal-to-File letter was issued on the BLA.
North Dakota State University economist Raymond March faults the way in which FDA provides risk management guidance to regulated companies.
A cancer center precision medicine expert calls on FDA to require labeling changes for some non-small cell lung cancer immune checkpoint inhibitors to reflect emerging evidence that they are inappropriate for some populations.
