Post‐Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004–2014
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2679
Abstract: 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… read more here.
Keywords: medicines agency; european medicines; 2004 2014; cancer drugs ... See more keywords
Postmarketing requirements for drugs approved by the Food and Drug Administration for the treatment of solid tumor cancers, 2010-2019.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2021.39.15_suppl.e13597
Abstract: e13597Background: In recent years, efforts to improve the efficiency and speed of drug development and approval have driven a surge of Food and Drug Administration (FDA) approvals for cancer drugs.... read more here.
Keywords: drug; postmarketing requirements; food drug; drug administration ... See more keywords
Factors That Influence FDA Decisions for Postmarketing Requirements and Commitments During Review of Oncology Products.
Sign Up to like & getrecommendations! Published in 2018 at "Journal of oncology practice"
DOI: 10.1200/jop.2017.023234
Abstract: PURPOSE With the recent use of expedited drug development and approval programs for several oncology products in the United States, the importance of postmarketing plans to confirm clinical benefits and safety is increasing. To discuss… read more here.
Keywords: fda decisions; postmarketing requirements; oncology products; oncology ... See more keywords