Infographics related to Regulatory Affairs and CMC
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Time is rapidly running out to transition ongoing clinical trials in the EU to the new framework of the Clinical Trials Regulation (CTR). A key challenge for sponsors is ensuring they are proficient in the Clinical Trial Information System (CTIS) and understand the transition requirements.
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Meetings with the FDA are extremely beneficial to build a relationship that will last many years Meetings with the US Food and Drug Administration (FDA) help you create a viable regulatory strategy and also ensure your drug is on the best path to receiving market approval. Typically, FDA meetings will only last one hour, and you will only have one chance to get it right, so it’s vital they run smoothly so that you meet your objectives. PharmaLex US expert Mark Lane has laid out a clear step-by-step guide to meeting with the FDA to help you get the