We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Having operational logistics in place for your FDA inspection means writing down the inspection plan beforehand in a standard operating procedure (SOP), starting with the moment the investigators walk in the door, advised inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.
Four out of 10 women don’t receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which leads to additional visits because of persistent symptoms, the company said.
Among the many requirements to bring your product to market is to have accurate labeling — as well as procedures in place to ensure that and any new intended uses are included.
The FDA handed Oak Ridge Products a Form 483 for a lack of design control documents as well as inadequate corrective and preventive action (CAPA) procedures and complaint handling, among other lapses.
The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that.
The FDA offers recommendations for using electronic systems, records and signatures in clinical trials, including advice on validation, in a draft guidance released Wednesday.
Visby Medical’s in-office test for sexually-transmitted infections (STIs) in women that delivers 97 percent accurate results in 30 minutes — not the usual two to five days with laboratory testing — just received FDA clearance, enabling diagnosis and treatment in the same office visit.