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Sharan Murugan
Oct 4, 20232 min read
USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications
The FDA revised section 5200.14 of the Manual of Policies and Procedures (MAPP), "Filing Reviews of Abbreviated New Drug Applications...
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Sharan Murugan
Nov 12, 20221 min read
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...
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Sharan Murugan
Oct 6, 20222 min read
USFDA Guidance : GDUFA III User Fees & 4 Generic Drug related Guidances
USFDA finalized and released four Guidelines yesterday (05 October 2022), in accordance with the time frames set forth in the Generic...
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Sharan Murugan
Jun 16, 20221 min read
USFDA Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication
FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product...
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Sharan Murugan
Apr 17, 20221 min read
FDA's MAPP on Complex Product Classification for Generic Development
On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining...
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Sharan Murugan
Jul 28, 20211 min read
FDA’s revised MAPP Procedures for Generic Drug Labeling Change
FDA on July 26, 2021, published a revision to the Manual of Policies and Procedures (MAPP 5230.3), “Generic Drug Labeling Revisions” The...
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