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Sep 152 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...

Jun 202 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...

Jan 132 min read

USFDA Guidance: Requests for Reconsideration under GDUFA

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

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...

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The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...

Oct 17, 20221 min read

USFDA Guidance: ANDA Submissions – Prior Approval Supplements - Under GDUFA

Center for Drug Evaluation and Research (CDER) finalized and released updated guidance on "ANDA Submissions – Prior Approval Supplements...

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...