Search
Sharan Murugan
Aug 192 min read
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...
56 views0 comments
Sharan Murugan
Feb 19, 20232 min read
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...
34 views0 comments