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In this paper, we discuss the various opportunities the US Food and Drug Administration and the European Medicines Agency offer to expedite the drug development and regulatory approval timelines for drugs intended to treat serious diseases and unmet medical needs.</jats:p>","journal":"Clinical and Translational Science","year":2020,"id":53975,"datarank":3.06171650713533,"base_score":3.6109179126442243,"endowment":3.6109179126442243,"self_citation_contribution":0.5416376868966337,"citation_network_contribution":2.520078820238696,"self_endowment_contribution":0.5416376868966337,"citer_contribution":2.520078820238696,"corpus_percentile":null,"corpus_rank":null,"citation_count":36,"citer_count":36,"citers_with_citation_signal":27,"citers_with_endowment":27,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":276806,"name":"Anita V. 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Review by regulatory authorities to evaluate whether the data support a positive benefit/risk profile takes many months, adding additional time before patients may access therapy. In this paper, we discuss the various opportunities the US Food and Drug Administration and the European Medicines Agency offer to expedite the drug development and regulatory approval timelines for drugs intended to treat serious diseases and unmet medical needs.</jats:p>","is_dataset_classified":null,"base_score":3.6109179126442243,"endowment":3.6109179126442243,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"31909876","pmcid":"PMC7214660","openalex_id":"https://openalex.org/W2999793242","authors":[],"funders":[],"total_grants":0,"fwci":1.6001,"citation_percentile":0.85473096,"influential_citations":1,"citation_trend":[{"year":2019,"count":1},{"year":2020,"count":1},{"year":2021,"count":2},{"year":2022,"count":4},{"year":2023,"count":12},{"year":2024,"count":4},{"year":2025,"count":6},{"year":2026,"count":6}],"oa_status":"gold","license":"cc-by-nc-nd","oa_locations":[{"url":"https://ascpt.onlinelibrary.wiley.com/doi/pdfdirect/10.1111/cts.12745","host_type":"journal"},{"url":"https://ascpt.onlinelibrary.wiley.com/doi/pdfdirect/10.1111/cts.12745","host_type":"GOLD"},{"url":"https://ascpt.onlinelibrary.wiley.com/doi/pdfdirect/10.1111/cts.12745","host_type":"publisher"},{"url":"https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fcts.12745","host_type":"publisher"},{"url":"https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12745","host_type":"publisher"},{"url":"https://onlinelibrary.wiley.com/doi/full-xml/10.1111/cts.12745","host_type":"publisher"},{"url":"https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12745","host_type":"publisher"},{"url":"https://doi.org/10.1111/cts.12745","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/31909876","host_type":"repository"},{"url":"https://doaj.org/article/c2afed5e2556478299c4102e5d518c00","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/7214660","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC7214660","host_type":"Europe_PMC"},{"url":"https://europepmc.org/articles/PMC7214660?pdf=render","host_type":"Europe_PMC"}],"fields_of_study":["Cancer Treatment and Pharmacology","Health Systems, Economic Evaluations, Quality of Life","Statistical Methods in Clinical Trials","Medicine","Drug Approval","European Union","United States","United States Food and Drug Administration"],"mesh_terms":["European Union","United States","United States Food and Drug Administration","Drug Approval"],"keywords":["Regulatory affairs","Regulatory science","Marketing authorization","Authorization","Regulatory agency","Food and drug administration","Drug approval","Timeline","Regulatory authority","Medicine","Agency (philosophy)","Drug development","Clinical trial","MEDLINE","Prior authorization","Business","Drug","Pharmacology","Political science","Bioinformatics","Public administration","Computer security","Pathology"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-07-18T20:58:06.232742Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}