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News dal mondo

19

Nov

FDA official discusses benefits, challenges of remote inspections

The use of remote regulatory assessments (RRAs) has helped the US Food and Drug Administration (FDA) identify “significantly deficient” good manufacturing practice (GMP) violations when officials cannot visit sites. Yet the program does pose some technical and logistical challenges, which can interfere with a manufacturer’s ability to respond to requests for records...[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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