Search
Sharan Murugan
- Oct 4, 2023
- 2 min
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...
83 views0 comments
Sharan Murugan
- Nov 12, 2022
- 1 min
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...
32 views0 comments
Sharan Murugan
- Oct 6, 2022
- 2 min
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...
66 views0 comments
Sharan Murugan
- Jun 16, 2022
- 1 min
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...
29 views0 comments
Sharan Murugan
- Apr 17, 2022
- 1 min
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...
11 views0 comments
Sharan Murugan
- Jul 28, 2021
- 1 min
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...
8 views0 comments