Webcast Links posted for June 19-20, 2019 Circulatory System Devices Panel The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee.  The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.  The meeting will be open …

FDA issues Draft Guidance for Industry on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations  FDA released Draft Guidance for Industry: “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations”. This draft guidance describes the Agency’s recommendations for the design and evaluation of comparative analytical studies, including considerations for the development of a comparative …

Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids The opioid tragedy has become one of the defining public health crises of modern times. As the rates of opioid addiction and overdose continue to grow, addressing the opioid crisis has taken on more urgency. For the …

GMP – MUTUAL RECOGNITION AGREEMENT WITH THE USA EU Mutual Recognition agreements – see section on the USA. In transition until July 2019. Now 24 Member States are recognised to perform inspections on behalf of the FDA.https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra Update: Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 30 April …

EPSL Regulatory Consulting
Legal Privacy All content © ESPL Regulatory Consulting
Registered Office: 71-75 Shelton Street, Covent Garden, London, United Kingdom, WC2H 9JQ
Website by Denvir