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31

Gen

FDA Publishes FY 22 GDUFA Science and Research Report

FDA’s Center for Drug Evaluation and Research  published its Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research Report.

The GDUFA Science and Research Program supports the development of safe, effective, and high-quality generic drugs for Americans through research and development of innovative methodologies and more efficient tools for demonstrating generic drug product quality and equivalence. The research focuses on overcoming scientific challenges for generic product development in the areas that FDA—working collaboratively with the generic drug industry, academia, and other stakeholders—identifies to be priorities each fiscal year.

This report summarizes the program’s progress and highlights the research outcomes for the 13 research priority topic areas for FY 2022. The report also includes information on eight new research contracts and seven new grants (not including supplements to existing projects) that FDA awarded for innovative generic drug-related extramural research projects, as well as more than 70 intramural research projects to improve generic drug development and regulatory assessment.

24

Mar

AIFA - Criteri per l’attribuzione di distinti numeri di AIC in fase di domanda di nuova AIC/estensione o a seguito di variazione

Si informano i Titolari AIC che, al fine di rendere trasparenti i criteri adottati dall’Agenzia...

23

Mar

IMS Micronizzazioni: “Making Pharmaceuticals per parlare delle ultime novità in campo di micronizzazione”

Il settore farmaceutico si riunisce a Milano per fare il punto sulle ultime novità e sulle prospettive...

23

Mar

EDQM - What is the CEP 2.0 and what will change?

The CEP 2.0 (new name of the CEP of the future) is a “new-look” CEP that will better meet...

17

Mar

EMA - EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME

Audit Checklist (Revision 3 including API and common with Canada and PIC/S).. [EMA]

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