Post‐Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004–2014

To address unresolved questions about drug safety and efficacy at the time of approval, the European Medicines Agency (EMA) may require that manufacturers conduct additional studies during the postmarketing period. As a growing proportion of new cancer drugs are approved on the basis of limited evid...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2022-10, Vol.112 (4), p.846-852
Main Authors: Cherla, Avi, Mossialos, Elias, Salcher‐Konrad, Maximilian, Kesselheim, Aaron S., Naci, Huseyin
Format: Article
Language:English
Subjects:
Antineoplastic Agents - adverse effects
Drug Approval
Europe
Humans
Neoplasms - drug therapy
Product Surveillance, Postmarketing
Randomized Controlled Trials as Topic
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