Cargando…

Regulation of immunotherapeutic products for cancer and FDA’s role in product development and clinical evaluation

Immunotherapeutics include drugs and biologics that render therapeutic benefit by harnessing the power of the immune system. The promise of immune-mediated therapies is target specificity with a consequent reduction in off-target side effects. Recent scientific advances have led to clinical trials o...

Descripción completa

Detalles Bibliográficos
Autores principales:	Vatsan, Ramjay S, Bross, Peter F, Liu, Ke, Theoret, Marc, De Claro, Angelo R, Lu, Jinhua, Helms, Whitney, Niland, Brian, Husain, Syed R, Puri, Raj K
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2013
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3986979/ https://www.ncbi.nlm.nih.gov/pubmed/24764535 http://dx.doi.org/10.1186/2051-1426-1-5

Ejemplares similares

Generation of interleukin-13 receptor alpha2 antigen expressing modified vaccinia ankara recombinant virus for potential cancer immunotherapy
por: Sato, Yuki, et al.
Publicado: (2014)

Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
por: Kesselheim, Aaron S., et al.
Publicado: (2016)

The effects of lobbying on the FDA’s recall classification
por: Zhou, Yifan
Publicado: (2023)

Physician Perceptions of the FDA’s Breakthrough Therapy Designation: An Update
por: Paquin, Ryan S, et al.
Publicado: (2022)

LAWS, REGULATIONS, AND POLICY: Genetically Engineered Salmon on the FDA’s Table
por: Taylor, David A.
Publicado: (2010)

The FDA’s Experience with Emerging Genomics Technologies—Past, Present, and Future
por: Xu, Joshua, et al.
Publicado: (2016)

FDA’s tracking and analysis of surveillance sampling isolates for outbreak detection
por: Blessington, Tyann, et al.
Publicado: (2017)

The FDA’s Regulatory Framework for Chimeric Antigen Receptor‐T Cell Therapies
por: Marks, Peter
Publicado: (2019)

Public perceptions of the FDA’s marketing authorization of Vuse on Twitter/X
por: Lee, Sarah, et al.
Publicado: (2023)

OpenFDA: an innovative platform providing access to a wealth of FDA’s publicly available data
por: Kass-Hout, Taha A, et al.
Publicado: (2016)

COVID-19 emergency responders in FDA’s Center for Drug Evaluation and Research
por: Gormley, Lieutenant Commander Andrea, et al.
Publicado: (2020)

FDA’s Strategies to Close the Health Equity Gap among Diverse Populations
por: Spinner, Jovonni, et al.
Publicado: (2021)

Awareness of and receptivity to FDA’s point-of-sale tobacco public education campaign
por: Dutra, Lauren M., et al.
Publicado: (2023)

FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
por: Yu, Lawrence X., et al.
Publicado: (2019)

WITHDRAWN: COVID-19 Emergency Responders in FDA’s Center for Drug Evaluation and Research
por: Gormley, LCDR Andrea, et al.
Publicado: (2020)

A Critical Analysis of the FDA’s Omics-Driven Pharmacodynamic Biomarkers to Establish Biosimilarity
por: Niazi, Sarfaraz K.
Publicado: (2023)

The FDA’s Diverse and Dynamic Activities in the Social and Behavioral Sciences: Advancing and Supporting Health Equity
por: Lee, Christine, et al.
Publicado: (2021)

Evaluating adverse effects of environmental agents in food: a brief critique of the US FDA’s criteria
por: Vandenberg, Laura N., et al.
Publicado: (2023)

Regenerative Medicine Therapies for Rare Diseases
por: Lapteva, Larissa, et al.
Publicado: (2018)

FDA’s Nozzle Numerical Simulation Challenge: Non-Newtonian Fluid Effects and Blood Damage
por: Trias, Miquel, et al.
Publicado: (2014)

Information to Improve Public Perceptions of the Food and Drug Administration (FDA’s) Tobacco Regulatory Role
por: Osman, Amira, et al.
Publicado: (2018)

Reporter’s occupation and source of adverse device event reports contained in the FDA’s MAUDE database
por: Kavanagh, Kevin T, et al.
Publicado: (2019)

Can the COVID-19 interstate travel restrictions help lift the FDA’s blood ban?
por: Dorfman, Doron
Publicado: (2020)

The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic
por: Diak, Ida-Lina, et al.
Publicado: (2022)

338. ChatGPT Conveys Incorrect Information about the FDA’s Antibiotic Boxed Warnings
por: Linfield, Rebecca, et al.
Publicado: (2023)

Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
por: Mooghali, Maryam, et al.
Publicado: (2023)

Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule
por: Kramer, Judith M., et al.
Publicado: (2014)

Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science
por: Rouse, Rodney, et al.
Publicado: (2017)

The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars
por: Niazi, Sarfaraz K.
Publicado: (2023)

Clinical studies involving probiotics: When FDA’s investigational new drug rubric applies—and when it may not
por: Degnan, Fred H.
Publicado: (2012)

A Primer to the Structure, Content and Linkage of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Files
por: Ensign, Lisa Garnsey, et al.
Publicado: (2017)

US FDA’s Assessment of the Benefit-risk of Cefiderocol for its Initial Complicated Urinary Tract Infection Indication
por: Echols, Roger M, et al.
Publicado: (2021)

The FDA’s standard-making process for medical digital health technologies: co-producing technological and organizational innovation
por: Lievevrouw, Elisa, et al.
Publicado: (2021)

Industrial Perspective on the Benefits Realized From the FDA’s Model‐Informed Drug Development Paired Meeting Pilot Program
por: Galluppi, Gerald R., et al.
Publicado: (2021)

Enhancing FDA’s Reach to Minorities and Under-Represented Groups through Training: Developing Culturally Competent Health Education Materials
por: Spinner, Jovonni R., et al.
Publicado: (2021)

Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA’s Benefit–Risk Framework to Calculate Net-Benefit Score and Benefit–Risk Ratio
por: Sun, Stephen, et al.
Publicado: (2020)

New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science
por: Chiu, Kimberly, et al.
Publicado: (2023)

A Call to Action to Track Generic Drug Quality Using Real-World Data and the FDA’s Sentinel Initiative
por: Brown, Joshua D.
Publicado: (2020)

Narrative Review: The FDA’s Perfunctory Approach of Dietary Supplement Regulations Giving Rise to Copious Reports of Adverse Events
por: Li, WeiQi, et al.
Publicado: (2023)

Could the vaginal wall sling still have a role after FDA’s warning? the functional outcomes at 20 years
por: Illiano, Ester, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_pst0gmjsmj8frvcbvq3f0ubitq