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RAPS RAC-GS
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RAPS RAC-GS Questions and Answers
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?
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Regulatory Affairs Certification (RAC) US
Regulatory Affairs Certification (Drugs)
TESTED 21 Nov 2024
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