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Germany's Merck KGaA said it filed marketing authorization applications with European and Swiss authorities for its Erbitux cancer drug, one of its most important future drugs.
More widely used in Europe than in the United States, the cards have long been promoted as the key to a cashless society as well as for identity and authorization applications.
The new rules will apply to data submitted as part of marketing authorization applications after 1 January 2015.
PBPK is increasingly submitted as part of marketing authorization applications (MAAs).
Thus, formal demonstration of bioequivalence alone is not meaningful to file marketing authorization applications (MAA) for generic GnRH formulations.
In light of this, the logical first step is not to start an initiative that calls for (external) re-analysis of study results, but would be to ensure sufficient allocation of methodological expertise in the assessment of marketing authorization applications.
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AB Science announced that the European Medicines Agency has accepted a conditional marketing authorization application for MST to treat amyotrophic lateral sclerosis.
They fall into two categories: architectures for providing an authorization framework, and generic authorization application programmer interfaces (APIs) for allowing applications access to the authorization services.
Séralini countered that his experiment was modeled after Monsanto's own 3-month study assessing the toxicity of maize NK603 as part of its market authorization application.
In 3 October 2016, AB Science announced that the EMA has accepted a conditional marketing authorization application for MST to treat ALS in human.
In addition, if trials results are used as part of a marketing authorization application for a medicinal product, researchers must submit clinical study reports within 30 days after the end of the authorization process whether the application is successful, rejected, or withdrawn.
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