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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...

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...

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...

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...

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...

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...