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English to Arabic translations [PRO]
Medical - Medical: Health Care / ethics/medical studies | | English term or phrase: Post-Approval | (Study Name) USA Post-Approval Study:
You are being invited by your doctor (referred to as your “Study Doctor”) to take part in a research study called (Study Name) Post-Approval Study (referred to as the “Study”). The purpose of this Study is to evaluate the continued safety and effectiveness of the xxxx System recently approved for use by the Food and Drug Administration (FDA) for the treatment of narrowed coronary arteries ... |
|   Alaa ZeineldineKudoZ activityQuestions: 215 (none open) ( 23 closed without grading) Answers: 1135
Egypt
| | Local time: 21:50
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| | الدراسة اللاحقة للموافقة | Explanation:
Post-approval study is a clinical study or other investigation required in the PMA approval order to gather specific information to address precise study objectives about an approved medical device. Post-approval study commitment is an agreement by the sponsor, and confirmed by FDA in writing, to conduct one or more post-approval studies. Completion of these studies will fulfill that post-approval study commitment.
In post-approval study commitments, drug developers, as a condition of regulatory approval, agree to conduct research on newly marketed prescription drugs
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Shazly
Egypt
Local time: 21:50
| Grading comment Thank you!
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