controlled correspondance
- Guideline or reference source
- FDAGDUFA Generic Drug User Fee Amendments 2012
- Definition
- FDA’S Office of Generic Drugs provides assistance to pharmaceutical firms and related industry regarding a variety of questions posed as "controlled documents." See http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm120610.htm2. Controlled correspondence does not include citizen petitions, petitions for reconsideration or requests for stay.
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