Slow Fingers Stall FDA Approvals
As Originally Published in Inc. Magazine
Slow Fingers Stall FDA Approvals
While the FDA has learned how to quickly get its approvals in the Federal Register, it still faces other slow downs.
From: Inc., Oct 1996 | By: Hal Plotkin
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In 1994 Roger Salquist, then Calgene’s CEO, complained that delays in printing his FDA approval in the Federal Register had forced him to plow under several fields of his genetically engineered Flavr Savr tomatoes. Well, the Federal Register is now on-line. The result: dramatic reduction in publication times, from months down to just two or three days. But now there are logjams of up to six weeks in the federal agencies where the approvals must be typed before they are forwarded to the register’s revved-up publishers. “We’re no longer waiting for the printing presses,” says D.C. lawyer Paul Hyman. “Now we’re waiting for the typing pool.”