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Open access

Research article

First published 2017-6

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

Raymond Perez, Patrick Archdeacon, Nancy Roach [...]

Clinical Trials

Open access

Research article

First published 2014-3

Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

Patrick Archdeacon, Cheryl Grandinetti, José M. Vega [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1996-1

Evaluation of Preclinical Findings for 10-Day IND Safety Reports: FDA Considerations

Kenneth L. Hastings, James G. Farrelly, Alan Taylor

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1993-10

Phase IIIB and Treatment IND Safety Reporting

Gerald A. Faich

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2014-7

Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

Judith M. Kramer, David Vock, Howard E. Greenberg [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2014-11

Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND

Sundeep S. Sethi, Judith M. Kramer, Suzanne Gagnon [...]

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 1994-04

An Examination of the Drug Review Process Within the United States

Phillip A. Johns

International Journal of Toxicology

Free access

Research article

First published 2020-9

Drug Development 101: A Primer

Lorrene A. Buckley, Ilona Bebenek, Paul D. Cornwell [...]

International Journal of Toxicology

Open access

Research article

First published 2023

Assessing adverse drug reaction reports for antidiabetic medications approved by the food and drug administration between 2012 and 2017: a pharmacovigilance study

Britney A. Stottlemyer, Michael C. McDermott, Mackenzie R. Minogue [...]

Therapeutic Advances in Drug Safety

Retricted access

Other

First published 2009-5

An Overview of Bridging Study Evaluation in Taiwan

Li-Li Su, Herng-Der Chern, I-Lin Ryan Lee [...]

Therapeutic Innovation & Regulatory Science

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