Archive for June 17, 2021

FDA Approves a Nasal Antihistamine for Nonprescription Use

The U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The…

FDA In Brief: FDA Announces Qualification of a Medical Device Development Tool to Help Assess Patient- Reported Outcomes with LASIK Surgery

The following quote is attributed to William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality, in the FDA’s Center for Devices…

FDA In Brief: FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

The following quote is attributed to William Maisel, M.D., director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological…