<--- Back to Details
First PageDocument Content
Clinical research / Clinical pharmacology / Therapeutics / United States Public Health Service / Biologic License Application / Biologic / New Drug Application / MODDERN Cures Act / Food and Drug Administration / Pharmaceutical sciences / Pharmacology
Date: 2013-08-07 14:25:14
Clinical research
Clinical pharmacology
Therapeutics
United States Public Health Service
Biologic License Application
Biologic
New Drug Application
MODDERN Cures Act
Food and Drug Administration
Pharmaceutical sciences
Pharmacology

Add to Reading List

Source URL: www.cms.gov

Download Document from Source Website

File Size: 20,08 KB

Share Document on Facebook

Similar Documents

Biotechnology / Pharmacology / Biology / Pharmaceutical sciences / Savient pharmaceuticals / Pegloticase / Food and Drug Administration / PEGylation / Forward-looking statement / Biopharmaceutical / Biologic license application

Microsoft Word - Savient Resubmits Biologics License Application for KRYSTEXXAdoc

DocID: 1qqBA - View Document

Clinical research / Food and Drug Administration / Pharmaceutical industry / Drug safety / Savient pharmaceuticals / Pharmaceuticals policy / Pegloticase / Biologic license application / PEGylation / Validation / Pharmacovigilance / Clinical trial

Microsoft Word - Savient Update on KRYSTEXXA BLA Filingdoc

DocID: 1ot1g - View Document

Pharmacology / Biosimilar / Center for Biologics Evaluation and Research / Biologic License Application / New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Investigational New Drug / Food and Drug Administration / Medicine / Health

PDF Document

DocID: 16eHM - View Document

Pharmaceutical sciences / Pharmacology / Clinical research / Pharmaceutical industry / Structured Product Labeling / Clinical trial / Biologic License Application / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Health

BLA Complete Response Letter

DocID: 14Ctf - View Document

Medicine / Pharmacology / Pharmaceutical industry / Validity / Clinical research / Center for Biologics Evaluation and Research / Validation / Biologic License Application / Assay / Science / Biotechnology / Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD[removed]MEMORANDUM Date:

DocID: XoPt - View Document