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News dal mondo

15

Nov

CSA vs. CSV - Industry seeks clarity and ICH Q9 alignment

Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with medical device production have asked the agency to align some of the language in the document with the recent International Council for Harmonisation’s (ICH) Q9 guidance, exclude system lifecycle tools from the guidance and include information on cybersecurity.
 
The draft guidance details a risk-based approach to “establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate” as well as steps for validating the software and its appropriate use...[RAPS]

01

Feb

FDA Updates Policy Manual on Voluntary Withdrawal of Approved ANDAs

The FDA has updated its Manual of Policies and Procedures (MAPP) concerning receiving and processing...

01

Feb

EMA update on shortages of antibiotics in the EU

EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met...

01

Feb

EMA pubblica la linea guida su classificazione dei medicinali veterinari ai fini della prescrizione

Il Comitato per i medicinali veterinari (CVMP) dell’EMA ha adottato la Guideline on the application...

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