Regulatory Considerations and Streamlined Development Programs for Antibacterial Drugs for Serious Bacterial Diseases.

Jang, Seong H

Jang, Seong H.

Affiliation

Jang SH; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Clin Pharmacol Ther ; 110(6): 1429-1431, 2021 12.

Article in En | MEDLINE | ID: mdl-33404098

Subject(s)

Anti-Bacterial Agents/therapeutic use; Bacterial Infections/drug therapy; Clinical Trials as Topic/legislation & jurisprudence; Drug Development/legislation & jurisprudence; Bacterial Infections/diagnosis; Clinical Trials as Topic/methods; Drug Development/methods; Humans

Fulltext

XML

PubMed Links

Search on Google

Full text: 1 Database: MEDLINE Main subject: Bacterial Infections / Clinical Trials as Topic / Drug Development / Anti-Bacterial Agents Type of study: Diagnostic_studies / Prognostic_studies Limits: Humans Language: En Year: 2021 Type: Article

Fulltext

XML

PubMed Links

Search on Google