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    WHO/IAEA tackle investigational radiopharmaceutical GMP in draft guidance

    The World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) have released a draft guideline on good manufacturing practices for investigational radiopharmaceuticals.   The March 2021 document is the first working draft of a revision to the existing guidelines on good manufacturing practices (GMP) for investigational products. Consultation is open through the end of April 2021, with a revised document expected to be worked up for public consu...
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    Nonclinical Recommendations for Radiopharmaceuticals: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Tuesday released draft guidance on nonclinical study recommendations for microdose radiopharmaceutical diagnostic drugs. The 7-page draft seeks to help developers of these microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing authorization. The draft specifically discusses how to refine nonclinical study recommendations for this class of dru...
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    European Regulatory Roundup: EMA Starts Consultation on Developing Drugs to Meet Needs of Older People (3 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Starts Consultation on Developing Drugs to Meet Needs of Older People The European Medicines Agency (EMA) is encouraging drug developers and regulators to consider the needs of older people when designing and assessing medicines and their packaging. EMA took the step to drive the development of products that cater to the difficulties some older people face when try...
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    Italian Medicines Agency Finds Major Deficiencies at Radiopharmaceutical Manufacturer

    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. AIFA says that based on its inspection from 8 October, Iason does not comply with good manufacturing practice (GMP) requirements. This is the third GMP non-compliance report posted to one part of EudraGMDP – the European database of pharmaceutical manufacturing violations -- in rece...