CPA | News | 2022 | Fda most drug gmp warning letters in fy2022 stemmed from onsite inspections

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News from the world

Nov

FDA: Most drug GMP warning letters in FY2022 stemmed from onsite inspections

A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year 2022 were the result of onsite inspections, reversing a pandemic-era trend of enforcement actions triggered by the use of alternative tools...[RAPS]

Feb

WHO is releasing an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.

WHO calls on regulators and governments to: detect and remove from circulation in their...

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...

Feb

EMA update on shortages of antibiotics in the EU

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

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...