e.alvarado2022-07-05T08:52:21+00:00May 4th, 2022|Categories: Meditrial|Tags: Clinical Development, Clinical Trial, DRUGS, Medical Devices, Pharmaceuticals|
Clinical development is a term traditionally used to define the entire process of bringing a new drug or medical device to market. It includes a pre-clinical phase to support human use and a clinical trial phase on patients, in compliance [...]
k.janecek2022-10-06T12:45:59+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: Clinical Trial, Complex Generic Drugs, DRUGS, EMA, Europe, European Union, FDA, Generic Drug, Hybrid Medicines, Innovation, medicines, PSA, Regulatory, USA|
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex [...]
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