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FDA Issues New Enforcement Policy for…
FDA issued this guidance to provide a policy to help expand the availability and capability of steril…
European Medicines Agency Issued Elec…
European Medicines Agency (EMA) has implemented a new system to issue electronic certificates for hum…
Medical Device Change Control Process
Globalization of the market has greatly enhanced competition and pressure on manufacturers to develop…
Regulatory Challenges for Combination…
In the dynamic and ever changing global regulatory outlook, the area of combination products is an ex…
FDA, MHRA Continues to Facilitate Acc…
As hospitals are in need of mechanical ventilation for an influx of patients due to coronavirus disea…
Building Regulatory Capacity: Best Pr…
Pharmaceutical companies are using various methodologies to ensure regulatory compliance with the hea…
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