Tag Archives: FDA

Richard Friedman, CDER/FDA Headlines PDA Education Lineup

Richard Friedman, Associate Director, Office of Compliance, CDER, FDA will present Regulatory Expectations – Pharmaceutical Manufacturing at the PDA Education Program taking place at INTERPHEX 2014. Friedman’s presentation is a part of the Industry Trends and Regulatory Expectations Session on … Continue reading

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FDA Rapid Approval Pathways

VIA IDEA Pharma by Partha Ghosh The Food & Drug Administration (FDA) published new draft guidance on expedited programmes for serious conditions in June 2013, intended to facilitate and expedite development and review of new drugs in serious/life-threatening conditions with … Continue reading

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Supply Chain Security – Myths and Legends

There is an  increased focus on safe and secure supply chains – reinforced by the statement by the FDA in their Strategic Priorities for 2011 – 2015 – Section 2.2  Strengthen the Safety and Integrity of the Global Supply Chain … Continue reading

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