Isn’t It Time to Update cGMPs?

Isn’t It Time to Update cGMPs?
PharmaManufacturing.com
FDA needs to improve its public communications and to connect older written guidances, such as cGMPs, to its new initiatives.
By Agnes Shanley, Editor in Chief
“Even if you’re on the right track, you’ll get run over if you just sit there.”
– Will Rogers
IN JUNE, the U.S. Food and Drug Administration (FDA) celebrated its hundredth anniversary quietly, with commemorative programs and a retrospective on its Web site. In the post-Vioxx, FDA-bashing era, the Agency wasn’t about to get carried away.
Unfortunately, not too many people cared all that much. Then, in the midst of all the staid festivities, came a blast from Rep. Henry Waxman whose office released a scathing report charging that FDA enforcement activity has weakened considerably during the Bush Administration (see "Waxman Thrusts, FDA Parries, No One Wins").

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