Chemistry, Manufacturing and Control (CMC) Evaluations of ANDA Submission in the USA
By: Akshatha G
.
Contributor(s): Anoop Narayanan V.
Publisher: Karnataka Indian journal of pharmaceutical education and research 2019Edition: Vol.53(3), Jul-Sep.Description: 514-420p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical education and researchSummary: Background: The Abbreviated New Drug Application commonly referred as ANDA is an application that contains data submitted to US FDA for the review and prospective marketing authorization of generic drugs. The conduct of the reviewing of the application is done by the Division of Filing Review (DFR), Office of Regulatory Operations (ORO) in the Office of Generic Drugs (OGD). The format of ANDA: USFDA recommends the submission of ANDA applications as per ICH Common Technical Document (CTD) format. Module 3: Module 3 of CTD contains Chemistry, Manufacturing and Control (CMC) information including all the supporting details verifying that was summarised in section 2.3 which is the quality overall summary. Evaluation of ANDA: For the evaluation of an Abbreviated New Drug Application in the US, its Office of Generic Drugs (OGD) has developed a Question-based Review (QbR) for its CMC section which is mainly focussed on the critical quality attributes. Conclusion: The implementation of Question-based Review programme is yielding good improvements in FDA’s division of Office of Generic Drugs (OGD), i.e., by advancing the review pattern of the ANDA CMC section without compromising quality and efficacy for the indication of the generic product.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
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Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2019912 |
Background: The Abbreviated New Drug Application commonly referred as ANDA is an application that contains data submitted to US FDA for the review and prospective marketing authorization of generic drugs. The conduct of the reviewing of the application is done by the Division of Filing Review (DFR), Office of Regulatory Operations (ORO) in the Office of Generic Drugs (OGD). The format of ANDA: USFDA recommends the submission of ANDA applications as per ICH Common Technical Document (CTD) format. Module 3: Module 3 of CTD contains Chemistry, Manufacturing and Control (CMC) information including all the supporting details verifying that was summarised in section 2.3 which is the quality overall summary. Evaluation of ANDA: For the evaluation of an Abbreviated New Drug Application in the US, its Office of Generic Drugs (OGD) has developed a Question-based Review (QbR) for its CMC section which is mainly focussed on the critical quality attributes. Conclusion: The implementation of Question-based Review programme is yielding good improvements in FDA’s division of Office of Generic Drugs (OGD), i.e., by advancing the review pattern of the ANDA CMC section without compromising quality and efficacy for the indication of the generic product.
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