Regulatory - Applied Clinical Trials

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Regulatory Zone
News, developments and strategies for clinical trials conduct in relation to the FDA, EMA and other global regulatory authorities overseeing the drug development industry.

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All Change for Pharma at the European Commission
October 1, 2014
Reshuffling to heavily impact life sciences policy in Europe.
Rare Disease and Orphan Drugs: Regulatory Decisions
August 1, 2014
There are 7,000 rare diseases affecting approximately 350 million people around the world.
The U.S. Biosimilar Approval Pathway: Policy Precedes Science; A Regulatory Perspective
July 15, 2014
With the passage of the Biosimilar Price Competition and Innovation Act in 2009, the U.S. created new pathways for development and approval of biosimilar and interchangeable products.
Pharmacovigilance Outsourcing a Plus
June 24, 2014
Pharmacovigilance is the next frontier for outsourcing in the pharmaceutical and biologics industry.
Questions and Hopes on New EU Drug Legislation
June 1, 2014
Claims of success for pharmacovigilance are under question, but hopes are higher for new clinical trials rules.
Articles By Category
US
FDA-specific news, columns, and articles.
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EU
Latest news, columns, and articles about EMEA.
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Other Regions
Regulatory updates from worldwide regions
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 November 2012
EMA Boosts EU Transparency with Online Publication of Suspected Side Effect Reports
New Agency to Soon Replace French AFSSAPS
Eric Abadie Resigns as Chair of the CHMP
High Court to Rule on Health Reform Legality
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