Slow Fingers Stall FDA Approvals

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.”

About the Author /

hplotkin@plotkin.com

<p>My published work since 1985 has focused mostly on public policy, technology, science, education and business. I’ve written more than 600 articles for a variety of magazines, journals and newspapers on these often interrelated subjects. The topics I have covered include analysis of progressive approaches to higher education, entrepreneurial trends, e-learning strategies, business management, open source software, alternative energy research and development, voting technologies, streaming media platforms, online electioneering, biotech research, patent and tax law reform, federal nanotechnology policies and tech stocks.</p>