Search Results for radiopharmaceuticals

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Nonclinical Recommendations for Radiopharmaceuticals: FDA Drafts Guidance By Zachary Brennan - Published 12 September 2017

The US Food and Drug Administration (FDA) on Tuesday released draft guidance on nonclinical study recommendations for microdose radiopharmaceutical diagnostic drugs.

Categories: News, US, FDA, Drugs, Government affairs, Preclinical, Research and development

Tags: radiopharmaceuticals, nonclinical recommendations, FDA draft guidance

European Regulatory Roundup: EMA Starts Consultation on Developing Drugs to Meet Needs of Older People (3 August 2017) By Nick Paul Taylor - Published 03 August 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: European regulatory roundup, drugs for older people, radiopharmaceuticals

Italian Medicines Agency Finds Major Deficiencies at Radiopharmaceutical Manufacturer By Zachary Brennan - Published 02 December 2015

The Italian Medicines Agency (AIFA) released a non-compliance report on Wednesday for the Rome-based radiopharmaceutical manufacturer Iason Italia with deficiencies linked to quality issues.

Categories: News, Europe, EC, Compliance, Crisis management, Drugs, Manufacturing, Quality

Tags: AIFA, Italian Medicines Agency, Iason, Italian pharmaceutical manufacturing, radiopharmaceuticals