Monday, March 29, 2010

"The FOIA Packet": FDA's Nasonex® Briefing Materials Now Online

To its enduring credit, FDA's transparency initiative is paying dividends -- in the form of online access to pre-1998 review packets, for several of the most-widely prescribed drugs in the US -- ones for which, until now, electronic versions of the original records were rather scarce (due to the FDA approval having predated the more internet-friendly FDA approval process, and no funding for "backward" digitizing of the archived approvals). Click here to see the full 630 page PDF file on Nasonex®.

FDA has been placing the background materials, and public portions of the approval files online, and the ones thus far available are listed, and linked, in this FDA Transparency blog posting, posted on St. Patrick's Day, 2010.

. . . .The posted records are from the agency’s historical file of information that was previously disclosed under the Freedom of Information Act. The records are posted as is and have not been previously posted due to the quality of some of the records. The best available copies have been posted. . . .

Here's a peek -- at what lies, within (page 341 of 630) -- click it to biggify:

Just think -- this is, even after all these years -- a $164 million per year franchise. Wow.

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