Search Results - "Investigational New Drug Application"

Analysis of Regulatory Botanical Submission Profile for Cancer Management from the U.S. FDA Perspectives.

Authors: Park JK Lee D Rui L et al.

Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 Sep; Vol. 59 (5), pp. 1129-1137. Date of Electronic Publication: 2025 Jun 04.

Publication Type: Journal Article

Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

MeSH Terms: Neoplasms*/drug therapy , Drug Approval* , Investigational New Drug Application* , Phytotherapy*, United States ; United States Food and Drug Administration ; Humans ; Databases, Factual ; Clinical Trials as Topic

Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights.

Authors: Pawar J Hegde N Sharma S

Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 May; Vol. 59 (3), pp. 426-437. Date of Electronic Publication: 2025 Feb 08.

Publication Type: Journal Article; Review

Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

MeSH Terms: Drug Approval* , Drugs, Generic* , Investigational New Drug Application*, United States ; United States Food and Drug Administration ; Humans ; Therapeutic Equivalency

Cancer drug applications to the EMA and the FDA: A comparison of new drugs and extension of indication in terms of approval decisions and time in review.

Authors: Cramer A Sørup FKH Christensen HR et al.

Source: British journal of clinical pharmacology [Br J Clin Pharmacol] 2025 May; Vol. 91 (5), pp. 1431-1438. Date of Electronic Publication: 2025 Jan 07.

Publication Type: Journal Article; Comparative Study

Journal Info: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2125 (Electronic) Linking ISSN: 03065251 NLM ISO Abbreviation: Br J Clin Pharmacol Subsets: MEDLINE

MeSH Terms: United States Food and Drug Administration*/statistics & numerical data , Drug Approval*/organization & administration , Antineoplastic Agents*/therapeutic use , Neoplasms*/drug therapy , Investigational New Drug Application*, United States ; Humans ; Retrospective Studies ; Time Factors ; European Union ; Europe ; Decision Making

Concordance Between Pharmaceuticals and Medical Devices Agency Review and Ministry of Health, Labour and Welfare Decision Among New Drug Applications in Japan.

Authors: Miyazawa M Tanaka M Tanaka Y et al.

Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2025 Feb; Vol. 117 (2), pp. 544-553. Date of Electronic Publication: 2024 Nov 08.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE

MeSH Terms: Drug Approval*/legislation & jurisprudence , Government Agencies* , Investigational New Drug Application*/legislation & jurisprudence, Japan ; Humans ; Retrospective Studies ; Decision Making

Regulatory considerations for developing a phase I investigational new drug application for autologous induced pluripotent stem cells-based therapy product.

Authors: Jha BS Farnoodian M Bharti K

Source: Stem cells translational medicine [Stem Cells Transl Med] 2021 Feb; Vol. 10 (2), pp. 198-208. Date of Electronic Publication: 2020 Sep 18.

Publication Type: Journal Article; Review

Journal Info: Publisher: Oxford University Press Country of Publication: England NLM ID: 101578022 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2157-6580 (Electronic) Linking ISSN: 21576564 NLM ISO Abbreviation: Stem Cells Transl Med Subsets: MEDLINE

MeSH Terms: Induced Pluripotent Stem Cells* , Investigational New Drug Application*, Regenerative Medicine/*legislation & jurisprudence , Transplantation, Autologous/*legislation & jurisprudence, Cell Differentiation ; Humans

Regulatory Considerations for Producing mRNA Vaccines for Clinical Trials.

Authors: Schmid A; Albstadt-Sigmaringen University, Sigmaringen, Germany. schmida@hs-albsig.de.

Source: Methods in molecular biology (Clifton, N.J.) [Methods Mol Biol] 2024; Vol. 2786, pp. 321-337.

Publication Type: Journal Article

Journal Info: Publisher: Humana Press Country of Publication: United States NLM ID: 9214969 Publication Model: Print Cited Medium: Internet ISSN: 1940-6029 (Electronic) Linking ISSN: 10643745 NLM ISO Abbreviation: Methods Mol Biol Subsets: MEDLINE

MeSH Terms: Clinical Trials as Topic* , mRNA Vaccines* , Quality Control*, Humans ; RNA, Messenger/genetics ; United States ; Investigational New Drug Application ; Vaccines, Synthetic

Considerations on chemistry, manufacturing, and control of stem cell products for Investigational New Drug application in China.

Authors: Lu J Wei W

Source: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2020 Nov; Vol. 68, pp. 3-8. Date of Electronic Publication: 2020 Oct 20.

Publication Type: Journal Article; Review

Journal Info: Publisher: Academic Press Country of Publication: England NLM ID: 9004494 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-8320 (Electronic) Linking ISSN: 10451056 NLM ISO Abbreviation: Biologicals Subsets: MEDLINE

MeSH Terms: Cell Differentiation*, Cell- and Tissue-Based Therapy/*methods , Investigational New Drug Application/*methods , Mesenchymal Stem Cells/*cytology , Pluripotent Stem Cells/*cytology, Cell- and Tissue-Based Therapy/standards ; Chemistry, Pharmaceutical/methods ; China ; Drug Approval/methods ; Humans ; Investigational New Drug Application/legislation & jurisprudence ; Mesenchymal Stem Cells/chemistry ; Pluripotent Stem Cells/chemistry ; Quality Control

Ethical Drug Development for Rare Childhood Diseases: When There Are Limited But Promising Data in Adults, How to Choose Between Safety or Efficacy Studies?

Authors: Johnson LM Duenas DM Wilfond BS

Source: The American journal of bioethics : AJOB [Am J Bioeth] 2020 May; Vol. 20 (4), pp. 111-113.

Publication Type: Case Reports; Journal Article

Journal Info: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 100898738 Publication Model: Print Cited Medium: Internet ISSN: 1536-0075 (Electronic) Linking ISSN: 15265161 NLM ISO Abbreviation: Am J Bioeth Subsets: MEDLINE

MeSH Terms: Clinical Trial Protocols as Topic* , Ethics, Research* , Investigational New Drug Application* , Research Design*, Clinical Trials as Topic/*ethics , Drug Development/*ethics, Adolescent ; Humans ; Lupus Erythematosus, Systemic/prevention & control ; Minors ; Rare Diseases/prevention & control ; Risk ; United States ; United States Food and Drug Administration

Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective.

Authors: Wu C Lee SL Taylor C et al.

Source: Journal of natural products [J Nat Prod] 2020 Feb 28; Vol. 83 (2), pp. 552-562. Date of Electronic Publication: 2020 Jan 24.

Publication Type: Journal Article

Journal Info: Publisher: American Society of Pharmacognosy Country of Publication: United States NLM ID: 7906882 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6025 (Electronic) Linking ISSN: 01633864 NLM ISO Abbreviation: J Nat Prod Subsets: MEDLINE

MeSH Terms: Investigational New Drug Application*, Proanthocyanidins/*chemistry, Humans ; Molecular Structure ; Pharmaceutical Preparations ; United States

[New prescription procedures for authorisations for temporary use: A key step for access to innovation].

Transliterated Title: Nouvelles modalités de prescription des autorisations temporaires d’utilisation nominatives (ATUn) : une étape clé dans l’accès à l’innovation.

Authors: Vignot S Chapel E

Source: Bulletin du cancer [Bull Cancer] 2019 Nov; Vol. 106 (11), pp. 943-945. Date of Electronic Publication: 2019 Sep 25.

Publication Type: Editorial

Journal Info: Publisher: Elsevier Country of Publication: France NLM ID: 0072416 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1769-6917 (Electronic) Linking ISSN: 00074551 NLM ISO Abbreviation: Bull Cancer Subsets: MEDLINE

MeSH Terms: Diffusion of Innovation* , Investigational New Drug Application* , Therapies, Investigational*, Antineoplastic Agents/therapeutic use ; Antineoplastic Agents, Immunological/therapeutic use ; Clinical Trials as Topic ; Europe ; Hematologic Agents/therapeutic use ; Humans

Sterilized talc pleurodesis for malignant pleural effusions: a Phase II study for investigational new drug application in Japan.

Authors: Saka H Oki M Kitagawa C et al.

Source: Japanese journal of clinical oncology [Jpn J Clin Oncol] 2018 Apr 01; Vol. 48 (4), pp. 376-381.

Publication Type: Clinical Trial, Phase II; Journal Article

Journal Info: Publisher: Oxford University Press Country of Publication: England NLM ID: 0313225 Publication Model: Print Cited Medium: Internet ISSN: 1465-3621 (Electronic) Linking ISSN: 03682811 NLM ISO Abbreviation: Jpn J Clin Oncol Subsets: MEDLINE

MeSH Terms: Investigational New Drug Application* , Pleurodesis*/adverse effects , Sterilization*, Pleural Effusion, Malignant/*therapy , Talc/*therapeutic use, Adult ; Aged ; Endpoint Determination ; Female ; Humans ; Japan ; Male ; Middle Aged ; Talc/adverse effects ; Treatment Outcome

Quality Control Analysis of Mesenchymal Stem/Stromal Cells During Investigational New Drug Application for GvHD Administration in China.

Authors: Wang A Zhang L Zhao M et al.

Source: Current stem cell research & therapy [Curr Stem Cell Res Ther] 2023; Vol. 18 (8), pp. 1032-1040.

Publication Type: Journal Article

Journal Info: Publisher: Bentham Science Publishers Country of Publication: United Arab Emirates NLM ID: 101272517 Publication Model: Print Cited Medium: Internet ISSN: 2212-3946 (Electronic) Linking ISSN: 1574888X NLM ISO Abbreviation: Curr Stem Cell Res Ther Subsets: MEDLINE

MeSH Terms: Graft vs Host Disease*/therapy , Hematopoietic Stem Cell Transplantation* , Mesenchymal Stem Cells* , Mesenchymal Stem Cell Transplantation*, Humans ; Investigational New Drug Application ; Immunomodulation

Psychological Resilience as a Biomarker_ Developing_a Mathematical Model for Clinical Psychology_Applications

Authors: Al_Shawki, Yasser Mohammed Abdo Ali

Subject Terms: Pacemaker, Artificial, Psychology, Clinical, Sleep Aids, Pharmaceutical/cerebrospinal fluid, Climate Models, Digital land model, Resilience, Psychological/classification, Global model, Host Adaptation, Business models, Behavioral Symptoms/urine, Biomarkers, Pharmacological, Behavioral Sciences/methods, Nesting Behavior, Behavioral Symptoms/genetics, Mathematical model, Mathematics/economics, Arenaviruses, New World/enzymology, Adaptation, Psychological, Dangerous Behavior, Psychology, Resilience, Psychological/physiology, Camelids, New World/embryology, Artificial Life, Mathematical Computing, New technology, Residence Characteristics/classification, Environmental Biomarkers, Camelids, New World/parasitology, Adaptation, Physiological/radiation effects, Biomarkers/urine, Behavioral Symptoms/enzymology, Economics, Behavioral, Models, Cardiovascular, Biomarkers, Tumor/biosynthesis, Psychological effect, Biomarkers, Tumor/chemistry, Multitasking Behavior, Behavioral Symptoms/blood, Adaptation, Physiological/genetics, Adaptive Clinical Trials as Topic/trends, Mathematics/education, Models, Dental, Mathematical physics, Sucking Behavior, Adaptation, Biological/immunology, Behavioral Sciences, Agonistic Behavior, Arenaviruses, New World/genetics, Behavioral Research, Pancreas, Artificial, Arenaviruses, New World/classification, Adaptation, Psychological/radiation effects, Aspirations, Psychological, Drinking Behavior, Host Adaptation/physiology, Camelids, New World/microbiology, Residence Characteristics/statistics & numerical data, Computerized Adaptive Testing/methods, Biomarkers, Tumor/analysis, Behavior and Behavior Mechanisms, Behavioral Medicine, Camelids, New World/genetics, Clinical waste, Host Adaptation/drug effects, FOS: Mathematics, Adaptation, Biological/genetics, Pneumothorax, Artificial, Biomarkers/cerebrospinal fluid, Environmental Biomarkers/physiology, Biomarkers, Tumor/agonists, Social Behavior, Dr. Yasser's medical and scientific research, Ceremonial Behavior, Behavior, Sleep Aids, Pharmaceutical/analogs & derivatives, Resilience, Eye, Artificial, Pure mathematics, Clinical Coding, Mathematical Concepts, Biomarker, Models, Theoretical, Artificial satellite, Respiration, Artificial, Practice, Psychological, Behavioral Medicine/trends, Clinical medicine, Sleep Aids, Pharmaceutical, Arenaviruses, New World/immunology, Development model, Clinical Medicine, Environmental Biomarkers/genetics, Mathematics/ethics, Mathematics, Biomarkers, Health Belief Model, Camelids, New World/metabolism, Models, Anatomic, Models, Molecular, Behavior and Behavior Mechanisms/classification, Artificial intelligence, Dependency, Psychological, Behavioral Symptoms, Clinical Reasoning, Biomarkers/metabolism, Biomarkers/analysis, Behavioral Symptoms/nursing, Host Adaptation/radiation effects, Behavioral Symptoms/economics, Residence Characteristics, Cognitive psychology, Adaptation, Physiological/immunology, Behavioral Medicine/standards, Camelids, New World/surgery, Artificial lake, Adaptive Clinical Trials as Topic/adverse effects, Investigational New Drug Application, Residence Characteristics/history, Arenaviruses, New World, Insemination, Artificial, Mathematical method, New community, Ecological resilience, Adaptive Clinical Trials as Topic/psychology, Dark Adaptation/genetics, Resilience, Psychological, Discrete mathematics, Biomarkers/chemistry, Resilience, Psychological/ethics, Resilience, Psychological/radiation effects, Camelids, New World/virology, FOS: Psychology, Inhibition, Psychological, Behavioral Medicine/instrumentation, Biomarkers, Pharmacological/blood, Behavioral Sciences/standards, Camelids, New World/blood, Clinical Competence, Behavioral Symptoms/rehabilitation, Biomarkers, Tumor/genetics, Psychological Theory, Camelids, New World, Models, Educational, Models, Neurological, Artificial pancreas, Adaptation, Physiological/drug effects, Genetics, Behavioral, Heart, Artificial, Models, Psychological, Mathematical analysis, Artificial bone, Mathematics/standards, Artificial Intelligence, Biomarkers, Tumor, New town, New installation, Atmospheric model, Paternal Behavior, Mathematics/history, Behavioral Sciences/history, Skin, Artificial, Environmental Biomarkers/immunology, Mathematics/trends, Resilience, Psychological/drug effects, Adaptation, Psychological/drug effects, New material, Economic resilience, Adaptation, Ocular, FOS: Clinical medicine, Saliva, Artificial, Applied mathematics, Xenograft Model Antitumor Assays, Imitative Behavior, Dark Adaptation/physiology, Transtheoretical Model, Psychological stress, Ethics, Clinical, Models, Chemical, Mathematical logic, Epidemiological Models, Artificial Cells, Mathematics/classification, Behavioral Medicine/education, Artificial land, Larynx, Artificial, Ecosystem resilience, Biomarkers/blood, Model

U.S. Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs.

Authors: Dreher-Lesnick SM Stibitz S Carlson PE Jr

Source: Microbiology spectrum [Microbiol Spectr] 2017 Oct; Vol. 5 (5).

Publication Type: Journal Article

Journal Info: Publisher: ASM Press Country of Publication: United States NLM ID: 101634614 Publication Model: Print Cited Medium: Internet ISSN: 2165-0497 (Electronic) Linking ISSN: 21650497 NLM ISO Abbreviation: Microbiol Spectr Subsets: MEDLINE

MeSH Terms: Investigational New Drug Application*/legislation & jurisprudence, Biological Products/*standards , Biological Therapy/*standards, Bacteria/genetics ; Bacteria/metabolism ; Drug Approval/legislation & jurisprudence ; Drug Design ; Humans ; Manufacturing and Industrial Facilities/legislation & jurisprudence ; Microbiota ; Microorganisms, Genetically-Modified ; United States ; United States Food and Drug Administration/legislation & jurisprudence

Experience of an academic institute in importing a novel preclinical drug into India.

Authors: Kumar MP Medhi B

Source: Indian journal of pharmacology [Indian J Pharmacol] 2017 Jul-Aug; Vol. 49 (4), pp. 322-324.

Publication Type: Journal Article

Journal Info: Publisher: Medknow Publications Country of Publication: India NLM ID: 7902477 Publication Model: Print Cited Medium: Internet ISSN: 1998-3751 (Electronic) Linking ISSN: 02537613 NLM ISO Abbreviation: Indian J Pharmacol Subsets: MEDLINE

MeSH Terms: Drugs, Investigational* , Neuroprotective Agents* , Universities*/legislation & jurisprudence, Investigational New Drug Application/*methods , Transportation/*methods, Brazil ; Drug Evaluation, Preclinical/methods ; Humans ; India ; Investigational New Drug Application/legislation & jurisprudence ; Transportation/legislation & jurisprudence

Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

Authors: Perez R Archdeacon P Roach N et al.

Source: Clinical trials (London, England) [Clin Trials] 2017 Jun; Vol. 14 (3), pp. 225-233. Date of Electronic Publication: 2017 Mar 26.

Publication Type: Journal Article

Journal Info: Publisher: SAGE Publications Country of Publication: England NLM ID: 101197451 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1740-7753 (Electronic) Linking ISSN: 17407745 NLM ISO Abbreviation: Clin Trials Subsets: MEDLINE

MeSH Terms: Adverse Drug Reaction Reporting Systems/*standards , Clinical Trials as Topic/*standards , Drugs, Investigational/*adverse effects , Investigational New Drug Application/*legislation & jurisprudence, Adverse Drug Reaction Reporting Systems/legislation & jurisprudence ; Clinical Trials as Topic/legislation & jurisprudence ; Humans ; Investigational New Drug Application/methods ; Medical Oncology ; Qualitative Research ; Research Personnel ; Surveys and Questionnaires ; United States ; United States Food and Drug Administration

Analysis of secondary pharmacology assays received by the US Food and Drug Administration.

Authors: Scott C Dodson A Saulnier M et al.

Source: Journal of pharmacological and toxicological methods [J Pharmacol Toxicol Methods] 2022 Sep-Oct; Vol. 117, pp. 107205. Date of Electronic Publication: 2022 Aug 01.

Publication Type: Journal Article

Journal Info: Publisher: Elsevier Country of Publication: United States NLM ID: 9206091 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-488X (Electronic) Linking ISSN: 10568719 NLM ISO Abbreviation: J Pharmacol Toxicol Methods Subsets: MEDLINE

MeSH Terms: Drugs, Investigational* , Vesicular Monoamine Transport Proteins*, Histamine ; Humans ; Investigational New Drug Application/methods ; United States ; United States Food and Drug Administration

Development and Evaluation of a New Technological Way of Engaging Patients and Enhancing Understanding of Drug Tolerability in Early Clinical Development: PROACT.

Authors: Hughes A Landers D Arkenau HT et al.

Source: Advances in therapy [Adv Ther] 2016 Jun; Vol. 33 (6), pp. 1012-24. Date of Electronic Publication: 2016 May 11.

Publication Type: Journal Article

Journal Info: Publisher: Health Communications Inc Country of Publication: United States NLM ID: 8611864 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1865-8652 (Electronic) Linking ISSN: 0741238X NLM ISO Abbreviation: Adv Ther

MeSH Terms: Drug Tolerance* , Investigational New Drug Application*/methods , Investigational New Drug Application*/organization & administration , Patient Reported Outcome Measures* , Therapies, Investigational*/adverse effects , Therapies, Investigational*/methods, Patient Participation/*methods , Patient Safety/*standards, Confidentiality/standards ; Disclosure/standards ; Humans ; Pilot Projects ; Quality Improvement ; United Kingdom

Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold.

Authors: Lapteva L Pariser AR

Source: Journal of investigative medicine : the official publication of the American Federation for Clinical Research [J Investig Med] 2016 Feb; Vol. 64 (2), pp. 376-82.

Publication Type: Journal Article

Journal Info: Publisher: SAGE Publications Country of Publication: England NLM ID: 9501229 Publication Model: Print Cited Medium: Internet ISSN: 1708-8267 (Electronic) Linking ISSN: 10815589 NLM ISO Abbreviation: J Investig Med Subsets: MEDLINE

MeSH Terms: United States Food and Drug Administration*, Investigational New Drug Application/*methods , Investigational New Drug Application/*statistics & numerical data, Humans ; Investigational New Drug Application/legislation & jurisprudence ; Pilot Projects ; Time Factors ; United States

Successful regulatory agency interaction - A nonclinical regulatory strategist's perspective.

Authors: Baldrick P; Product Development and Market Access Consulting, Clinical Development & Commercialisation Services, Labcorp Drug Development Inc. (formerly Covance), Harrogate, North Yorkshire, HG3 1PY, United Kingdom. Electronic address: paul.baldrick@covance.com.

Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2022 Apr; Vol. 130, pp. 105130. Date of Electronic Publication: 2022 Feb 04.

Publication Type: Journal Article

Journal Info: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-0295 (Electronic) Linking ISSN: 02732300 NLM ISO Abbreviation: Regul Toxicol Pharmacol Subsets: MEDLINE

MeSH Terms: Interprofessional Relations*, Drug Approval/*organization & administration , Government Agencies/*organization & administration, Europe ; Humans ; Investigational New Drug Application/organization & administration ; Marketing/organization & administration