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November 02, 2015
The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.
September 15, 2015
Manufacturers challenge details in new policies designed to promote access to important therapies.
September 02, 2015
Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.
August 02, 2015
The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.
FDA and industry support global framework and collaborations to secure the supply chain.
July 02, 2015
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
June 02, 2015
Regulators and industry seek to streamline and harmonize oversight of postapproval changes.
May 02, 2015
The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.
May 01, 2015
Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.
April 02, 2015
More reliable operations would accelerate product development and prevent drug shortages.