1.

Record Nr.

UNINA9910698723803321

Titolo

Guidance for industry [[electronic resource] ] : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications

Pubbl/distr/stampa

Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research

Rockville, MD : , : Center for Biologics Evaluation and Research, , [2008]

Descrizione fisica

ii, 16 pages : digital, PDF file

Soggetti

Drug approval - United States

Electronic filing systems - United States

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Title from PDF title page (viewed on Apr. 23, 2009).

"June 2008."

"Revision 2."