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

por Archdeacon, Patrick, Grandinetti, Cheryl, Vega, José M., Balderson, David, Kramer, Judith M.
Publicado 2013

Patients with Rheumatic Diseases do not have an Increased Risk of MRSA Carrier Status

por Krämer, Judith, Triantafyllias, Konstantinos, Kohnen, Wolfgang, Leber, Martin, Dederichs-Masius, Ute, Zucker, Andrea, Körber, Jürgen, Schwarting, Andreas
Publicado 2018

Portfolio of Clinical Research in Adult Cardiovascular Disease as Reflected in ClinicalTrials.gov

por Alexander, Karen P., Kong, David F., Starr, Aijing Z., Kramer, Judith, Chiswell, Karen, Tasneem, Asba, Califf, Robert M.
Publicado 2013

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

por Kramer, Judith M., Vock, David, Greenberg, Howard E., Janning, Cheri, Szczech, Lynda, Salgo, Miklos, Gagnon, Suzanne, Ellenberg, Susan
Publicado 2014

The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations

por Wittes, Janet, Crowe, Brenda, Chuang-Stein, Christy, Guettner, Achim, Hall, David, Jiang, Qi, Odenheimer, Daniel, Xia, H. Amy, Kramer, Judith
Publicado 2015

Using Central IRBs for Multicenter Clinical Trials in the United States

por Flynn, Kathryn E., Hahn, Cynthia L., Kramer, Judith M., Check, Devon K., Dombeck, Carrie B., Bang, Soo, Perlmutter, Jane, Khin-Maung-Gyi, Felix A., Weinfurt, Kevin P.
Publicado 2013