While this FDA web upgrade is not breaking news (it first appeared in July 2016), it is worth knowing about. Previously hard to find documents, many requiring purchase from outside vendors or long FOIA wait times, may now be found instantaneously and free of charge. Included (among others) are EIRs, 483s, 483 responses, etc. To see available document types, go to the pulldown menu on the site entitled “Filter by Record Type”.
“The ORA Electronic Reading Room displays copies of ORA records. We are making these records publicly available either (1) proactively at our discretion or (2) because they are “frequently requested” per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information (see 21 CFR Part 20). For other ORA documents, please visit the ORA home page and the FDA Warning Letter page for other FDA documents, please visit the FDA Freedom of Information (FOI) page.” Click here to go to the site, or contact us for literature searches, FDA correspondence, scientific writing or research.