Regulatory Blog

FDA's Center for Drug Evaluation and Research revised the final guidance last week titled " ANDA Submissions | Amendments to Abbreviated...

The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...

On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...

The US FDA has released final guidance for industry applicants "Facility Readiness: Goal Date Decisions Under GDUFA" which helps assign...

Today (09 June 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated final guidance on "Assessing User Fees...

The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...

USFDA finalized and released four Guidelines yesterday (05 October 2022), in accordance with the time frames set forth in the Generic...

The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year...

On December 2,2021 the U.S. (FDA) published the Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research...

The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating...