Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and Efficacy Supplements and Their Public Disclosure by Applicants

por Chahal, Harinder Singh, Mukherjee, Sanjana, Sigelman, Daniel W., Temple, Robert
Publicado 2021

Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021

por Monge, Andrea N., Sigelman, Daniel W., Temple, Robert J., Chahal, Harinder Singh
Publicado 2022

Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study

por Lurie, Peter, Chahal, Harinder S, Sigelman, Daniel W, Stacy, Sylvie, Sclar, Joshua, Ddamulira, Barbara
Publicado 2015