Search results

Articles (7)

Journals (0)

1-7 of 7 results for IND safety reports

Sort by:

Relevance

Select all

Sort by:

Relevance

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 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

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

Retricted access

Research article

First published 2018-5

Safety Reporting

Jonathan Seltzer, Amit Bhattacharyya

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2019-12

Transplantation with GXHPC1 for Liver Cirrhosis: Phase 1 Trial

Ko-Chang Huang, Ming-Hsi Chuang, Zung-Sheng Lin [...]

Cell Transplantation

Free access

Correction

First published 2000-06

Erratas

Applied Biosafety