Regulatory News In Brief
This article was originally published in The Gray Sheet
FDA may publicize inspection reports: FDA is seeking input on whether it should publicly disclose key findings from inspection reports. Currently, Form 483 reports, which list observations made during an inspection of a firm, are not made public. Freedom of Information Act requests for the reports can take a long time because of the need to redact confidential trade secret information, FDA notes. In a Nov. 21 post on its 1Transparency Blog, FDA asks whether the reports should be redesigned to separate out a summary or key findings page that could quickly be made publicly available. Three commenters on the post supported the concept
You may also be interested in...
Campbell, professor of orthopedic surgery at the Children's Hospital of Philadelphia, spoke with “The Gray Sheet” about the challenges tied to establishing effective measures for studies evaluating children with orthopedic devices, and other issues.
FDA says its proposed adverse event reporting requirements for combination products will help manufacturers navigate the intricate array of reporting requirements for deaths and injuries
A greatly expanded drug and device surveillance program could do more harm than good without proper safeguards in place, according to participants at a Dec. 16 FDA-sponsored workshop