Search
Sharan Murugan
Sep 15, 20242 min read
USFDA Guidance: Amendments to Abbreviated New Drug Applications (ANDAs) Under GDUFA
FDA's Center for Drug Evaluation and Research revised the final guidance last week titled " ANDA Submissions | Amendments to Abbreviated...
56 views0 comments
Sharan Murugan
Aug 19, 20242 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
Jul 31, 20243 min read
USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...
43 views0 comments
Sharan Murugan
Jun 20, 20242 min read
USFDA Guidance: Facility Readiness: Goal Date Decisions Under GDUFA
The US FDA has released final guidance for industry applicants "Facility Readiness: Goal Date Decisions Under GDUFA" which helps assign...
45 views0 comments
Sharan Murugan
Jun 8, 20231 min read
USFDA Guidance: Assessing User Fees Under the GDUFA of 2022
Today (09 June 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated final guidance on "Assessing User Fees...
20 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The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...
35 views0 comments
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...
81 views0 comments
Sharan Murugan
May 18, 20221 min read
Generic Drug User Fee Guidance - Assessing User Fees - USFDA
The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year...
14 views0 comments
Sharan Murugan
Dec 5, 20211 min read
USFDA publishes FY 2022 GDUFA Science & Research Priority Initiatives & FY 2022 collaboration
On December 2,2021 the U.S. (FDA) published the Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research...
16 views0 comments
Sharan Murugan
Aug 13, 20212 min read
FY2022 User Fee Table -USFDA
The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating...
80 views0 comments