October 3, 2022

GDUFA III Drug Master File (DMF) Review Enhancements

Effective communication among ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals. The reauthorization of the […]
October 3, 2022

GDUFA III Controlled Correspondence Enhancements

Controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element […]
October 3, 2022

ANDA Assessment Program – GDUFA III Performance Goals and Program Enhancements

GDUFA III includes several enhancements to the abbreviated new drug application (ANDA) assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements […]
October 3, 2022

GDUFA III Enhancements to the Pre-ANDA Program

The Pre-Abbreviated New Drug Application (Pre-ANDA) Program is designed to assist prospective generic drug applicants in developing more complete submissions, promote a more efficient and effective […]
October 3, 2022

PDUFA VI: Fiscal Years 2018 – 2022

On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA). This new law includes the reauthorization of the Prescription […]
October 3, 2022

Split Real Time Application Review (STAR)

Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter[1], FDA is creating the Split Real Time Application Review (STAR) pilot program.   Overview FDA […]
October 3, 2022

April – June 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Afinitor (everolimus) Afinitor Disperz (everolimus) Rapamune (sirolimus) Zortress (everolimus) Drug interaction FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Jemperli (dostarlimab-gxly) Keytruda […]
October 1, 2022

PDUFA VI Commitment: Assessment in Support of Sentinel System

FDA is committed to enhancing the U.S. drug safety system and envisions the Sentinel System will strengthen FDA’s post-market surveillance capabilities. To support this effort, FDA […]
September 30, 2022

FDA grants accelerated approval to futibatinib for cholangiocarcinoma

On September 30, 2022, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.) for adult patients with previously treated, unresectable, locally […]
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