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CDRH FOIA Electronic Reading Room
The CDRH FOIA electronic reading room contains frequently requested information via the Freedom of Information Act from the Center for Devices and Radiological Health. -
Approved Risk Evaluation and Mitigation Strategies
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the... -
POCA -Phonetic Orthographic Computer Algorithm
POCA is a software that produces a data set used internally to assess the safety, and feasibility of proposed proprietary drug names. FDA product name safety evaluators have...
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