News dal mondo
09
Feb
Pharma expert discusses effort to standardize CMC quality information
The pharmaceutical industry and the US Food and Drug Administration (FDA) are collaborating on a structured...
06
US FDA proposes waiving GDUFA facility fees for domestic manufacturers
The US Food and Drug Administration (FDA) has proposed waiving annual facility fees for the first three...
Computer Software Assurance for Production and Quality Management System Software
FDA is issuing this guidance to provide recommendations on computer software assurance for computers...
04
FDA, EMA officials encourage companies to pilot eCTD 4.0
Companies should increase their efforts to address issues and test their electronic Common Technical...
le ultime news
09 Feb
06 Feb
04 Feb
03 Feb
China revises drug administration regulations to spur innovation, tighten oversight
02 Feb
USA - A Quality Tax for Foreign Drug Makers? The Links Between National Security, Trade Deals, and Drug Quality.
29 Gen
US FDA Announces PreCheck Implementation Roadmap
28 Gen
Industry wants more streamlining following recent EU reforms
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