comparemela.com

Latest Breaking News On - Docket number - Page 4 : comparemela.com

Electronic Submission of Expedited Safety Reports

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry

Drug-administration
Guidance-issuing-office
Docket-number
Drug-evaluation
Event-reporting-system

Providing Regulatory Submissions in Electronic Format: IND Safety Repo

Electronic Submissions

Drug-administration
Guidance-issuing-office
Oncology-center
Docket-number
Drug-evaluation
Biologics-evaluation
Regulatory-submissions
Electronic-format

FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products

This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Adm

Drug-administration
Guidance-issuing-office
International-conference-on-harmonisation
Docket-number
Drug-evaluation
Biologics-evaluation
Event-reporting-system
International-conference
Implementation-guideline

Iowa Northern Railway deal warrants heightened scrutiny

Scott Syroka: A filing with federal regulators noted the “national importance” of Canadian National's bid to acquire Iowa Northern Railway.

North-iowa-area-community-college
Iowa
United-states
Cedar-falls
Cedar-rapids
Hawkeye-community-college
Butler-county
Canada
Kirkwood-community-college
Canadian
Wayne-dralle
David-harmantas-shutterstock

Clinical Pharmacology Considerations for Antibody-Drug Conjugates Gui

Clinical Pharmacology

Guidance-issuing-office
Drug-administration
Docket-number
Drug-evaluation
Biologics-evaluation

vimarsana © 2020. All Rights Reserved.