{"id":"https://openalex.org/W89094205","doi":"https://doi.org/10.31887/dcns.2000.2.3/jtmitchel","title":"FDA relations during drug development","display_name":"FDA relations during drug development","publication_year":2000,"publication_date":"2000-09-30","ids":{"openalex":"https://openalex.org/W89094205","doi":"https://doi.org/10.31887/dcns.2000.2.3/jtmitchel","mag":"89094205","pmid":"https://pubmed.ncbi.nlm.nih.gov/22034136","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/3181610"},"language":"en","primary_location":{"id":"doi:10.31887/dcns.2000.2.3/jtmitchel","doi":"https://doi.org/10.31887/dcns.2000.2.3/jtmitchel","is_oa":true,"landing_page_url":"https://doi.org/10.31887/dcns.2000.2.3/jtmitchel","pdf_url":null,"source":{"id":"https://openalex.org/S3206652469","display_name":"Dialogues in Clinical Neuroscience","issn_l":"1294-8322","issn":["1294-8322","1958-5969"],"is_oa":false,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","doyens","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311259","host_organization_name":"Laboratoires Servier","host_organization_lineage":["https://openalex.org/P4310311259"],"host_organization_lineage_names":["Laboratoires Servier"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Dialogues in Clinical Neuroscience","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://doi.org/10.31887/dcns.2000.2.3/jtmitchel","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5112254969","display_name":"Jules T. Mitchel","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Jules T. Mitchel","raw_affiliation_strings":["Target Health Inc, New York, NY, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Target Health Inc, New York, NY, USA","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":["https://openalex.org/A5112254969"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":2,"citation_normalized_percentile":{"value":0.01152882,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":95},"biblio":{"volume":"2","issue":"3","first_page":"213","last_page":"217"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.5806000232696533,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.5806000232696533,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.14249999821186066,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.12110000103712082,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/drug-development","display_name":"drug development","score":0.9800000190734863},{"id":"https://openalex.org/keywords/regulatory-affairs","display_name":"regulatory affairs","score":0.7580000162124634},{"id":"https://openalex.org/keywords/regulatory-communication","display_name":"regulatory communication","score":0.46399998664855957},{"id":"https://openalex.org/keywords/drug-approval","display_name":"drug approval","score":0.5320000052452087},{"id":"https://openalex.org/keywords/pharmaceutical-industry","display_name":"pharmaceutical industry","score":0.8529999852180481}],"concepts":[{"id":"https://openalex.org/C64903051","wikidata":"https://www.wikidata.org/wiki/Q2198549","display_name":"Drug development","level":3,"score":0.724926769733429},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.7084025144577026},{"id":"https://openalex.org/C2780511413","wikidata":"https://www.wikidata.org/wiki/Q18749628","display_name":"Regulatory affairs","level":2,"score":0.7063063383102417},{"id":"https://openalex.org/C2776876202","wikidata":"https://www.wikidata.org/wiki/Q1368197","display_name":"New drug application","level":3,"score":0.6533012390136719},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.6014218926429749},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.4805651009082794},{"id":"https://openalex.org/C2778917124","wikidata":"https://www.wikidata.org/wiki/Q7309705","display_name":"Regulatory science","level":2,"score":0.466383695602417},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.4325127601623535},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.3873897194862366},{"id":"https://openalex.org/C39549134","wikidata":"https://www.wikidata.org/wiki/Q133080","display_name":"Public relations","level":1,"score":0.3565298318862915},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.2530040740966797},{"id":"https://openalex.org/C3116431","wikidata":"https://www.wikidata.org/wiki/Q31728","display_name":"Public administration","level":1,"score":0.16956791281700134},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0}],"mesh":[],"locations_count":4,"locations":[{"id":"doi:10.31887/dcns.2000.2.3/jtmitchel","doi":"https://doi.org/10.31887/dcns.2000.2.3/jtmitchel","is_oa":true,"landing_page_url":"https://doi.org/10.31887/dcns.2000.2.3/jtmitchel","pdf_url":null,"source":{"id":"https://openalex.org/S3206652469","display_name":"Dialogues in Clinical Neuroscience","issn_l":"1294-8322","issn":["1294-8322","1958-5969"],"is_oa":false,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","doyens","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311259","host_organization_name":"Laboratoires Servier","host_organization_lineage":["https://openalex.org/P4310311259"],"host_organization_lineage_names":["Laboratoires Servier"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Dialogues in Clinical Neuroscience","raw_type":"journal-article"},{"id":"pmh:oai:europepmc.org:2202848","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/3181610","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":null,"raw_type":"Text"},{"id":"pmh:oai:pubmedcentral.nih.gov:3181610","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/3181610","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Dialogues Clin Neurosci","raw_type":"Text"},{"id":"pmid:22034136","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/22034136","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Dialogues in clinical neuroscience","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.31887/dcns.2000.2.3/jtmitchel","doi":"https://doi.org/10.31887/dcns.2000.2.3/jtmitchel","is_oa":true,"landing_page_url":"https://doi.org/10.31887/dcns.2000.2.3/jtmitchel","pdf_url":null,"source":{"id":"https://openalex.org/S3206652469","display_name":"Dialogues in Clinical Neuroscience","issn_l":"1294-8322","issn":["1294-8322","1958-5969"],"is_oa":false,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","doyens","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311259","host_organization_name":"Laboratoires Servier","host_organization_lineage":["https://openalex.org/P4310311259"],"host_organization_lineage_names":["Laboratoires Servier"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Dialogues in Clinical Neuroscience","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.504800021648407,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":1,"referenced_works":["https://openalex.org/W4298432253"],"related_works":["https://openalex.org/W3121649172","https://openalex.org/W2010159665","https://openalex.org/W2507876648","https://openalex.org/W2066301304","https://openalex.org/W2080421028","https://openalex.org/W2183525577","https://openalex.org/W7220613644","https://openalex.org/W1970843299","https://openalex.org/W4242764009","https://openalex.org/W4414962157"],"abstract_inverted_index":{"Working":[0],"closely":[1],"and":[2,43,50,65,77],"cooperatively":[3],"with":[4,85],"regulatory":[5,38],"authorities":[6],"during":[7],"drug":[8,14,22,34,62,67,97],"development":[9,15,23,98],"is":[10],"vital":[11],"to":[12],"successful":[13,96],"programs.":[16],"In":[17],"the":[18,21,30,48,59,86,88,92],"United":[19],"States,":[20],"team":[24],"includes":[25],"not":[26],"only":[27],"members":[28],"of":[29,33,94],"key":[31],"disciplines":[32],"discovery,":[35],"clinical":[36],"research,":[37],"affairs,":[39],"marketing,":[40],"chemistry,":[41],"toxicology,":[42],"legal":[44],"aspects,":[45],"but":[46],"also":[47,80],"Food":[49],"Drug":[51],"Administration":[52],"(FDA).":[53],"New":[54],"regulations":[55],"encourage":[56],"meetings":[57],"at":[58],"pre-investigational":[60],"new":[61],"(pre-IND),":[63],"end-of-phase-2,":[64],"pre-new":[66],"application":[68],"(pre-NDA)":[69],"submission":[70],"phases.":[71],"Appropriate":[72],"informal":[73],"discussions":[74],"via":[75],"fax":[76],"telephone":[78],"are":[79],"encouraged.":[81],"By":[82],"proactively":[83],"interacting":[84],"FDA,":[87],"pharmaceutical":[89],"industry":[90],"increases":[91],"probability":[93],"a":[95],"program.":[99]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2024,"cited_by_count":1}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2016-06-24T00:00:00"}