The Stakes Are High So Get It Right: CHMP Oral Explanations & FDA AdComs
The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. How they perform is critical. Consultant Kate Dion has a raft of helpful tips for companies facing this daunting situation. Neena Brizmohun reports.
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The European Medicines Agency’s first management board meeting of 2020 was held virtually and was shortened but covered a number of topics including COVID-19.
Companies developing new AML treatments are among those being called before the European Medicines Agency this week for questioning over marketing applications approaching the end of the review process.
The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.