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Summary basis for approval

Arabic translation: موجز أساس الموافقة

02:25 Sep 5, 2020
English to Arabic translations [PRO]
Medical - Medical: Pharmaceuticals / Certificate of a pharmaceutical product
English term or phrase: Summary basis for approval
Is the summary basis for approval appended?

This is a question found in a Certificate of a pharmaceutical product

Thank you for your help!
Malika El khadhri
France
Local time: 08:48
Arabic translation:موجز أساس الموافقة
Explanation:
I could not find any existing translation of this term in Arabic.
This is my suggestion based on the definition provided on the FDA site

(ii) For an application approved on or after July 1, 1975, a Summary Basis of Approval (SBA) document that contains a summary of the safety and effectiveness data and information evaluated by FDA during the drug approval process. The SBA is prepared in one of the following ways:

(a ) Before approval of the application, the applicant may prepare a draft SBA which the Center for Drug Evaluation and Research will review and may revise. The draft may be submitted with the application or as an amendment.

(b ) The Center for Drug Evaluation and Research may prepare the SBA.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfr...
Selected response from:

Hassan Achahbar
Morocco
Local time: 07:48
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1موجز أساس الموافقة
Hassan Achahbar
4ملخص جوهر الاتفاق
adel almergawy


  

Answers


40 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
summary basis of approval
موجز أساس الموافقة


Explanation:
I could not find any existing translation of this term in Arabic.
This is my suggestion based on the definition provided on the FDA site

(ii) For an application approved on or after July 1, 1975, a Summary Basis of Approval (SBA) document that contains a summary of the safety and effectiveness data and information evaluated by FDA during the drug approval process. The SBA is prepared in one of the following ways:

(a ) Before approval of the application, the applicant may prepare a draft SBA which the Center for Drug Evaluation and Research will review and may revise. The draft may be submitted with the application or as an amendment.

(b ) The Center for Drug Evaluation and Research may prepare the SBA.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfr...

Hassan Achahbar
Morocco
Local time: 07:48
Works in field
Native speaker of: Arabic
PRO pts in category: 24
Notes to answerer
Asker: Thank you so much!

Asker: Thank you very much for your help!


Peer comments on this answer (and responses from the answerer)
agree  Sajad Neisi
6 hrs
  -> Thanks a lot
Login to enter a peer comment (or grade)

5 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
ملخص جوهر الاتفاق


Explanation:
الموافقة

adel almergawy
Egypt
Local time: 08:48
Native speaker of: Native in ArabicArabic
Notes to answerer
Asker: Thank you very much !

Login to enter a peer comment (or grade)



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