The rule of meetings: From listening comes wisdom and from speaking repentence
When you know one division of FDA you know one division---and often not even that one
It's not sufficient to have SOPs in place. The company must ensure that their busy staff are following them, and that there is a system to keep SOPs up-to-date.
Never describe anecdotal information as data
Success is based less on brilliant ideas than on excellent execution of those ideas.
SPILKERISMS
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Spilkerisms presents weekly postings of pithy comments and pearls from myself and others that will help people remember the principles, tips and lessons of developing, discovering, marketing, regulatorily approving and related topics for new pharmaceutical and medical products, including drugs, medical devices, biotechnology products, diagnostics, vaccines and others. These pearls will help avoid errors and increase one's chances of success. Reader feedback is welcomed. Readers wishing more information may visit my website (www.bertspilker.com) or email me at bspilker@comcast.net. My latest book "Guide to Drug Development: A Comprehensive Review and Assessment" is available from Lippincott, Williams and Wilkins in Philadelphia (pub. 2009).
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