Drug user

Results: 1369



#Item
301Health / Medicine / Pharmaceutical industry / Pharmacology / Clinical research / Prescription Drug User Fee Act / Federal Food /  Drug /  and Cosmetic Act / Abbreviated New Drug Application / Clinical trial / Food and Drug Administration / Pharmaceuticals policy / Pharmaceutical sciences

APPENDIX C ALLOWABLE AND EXCLUDED COSTS FOR THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS The FD&C Act as amended defines the “process for the review of human drug applications” and the costs that may be incl

Add to Reading List

Source URL: www.fda.gov

Language: English
302Clinical research / Pharmacology / Prescription Drug User Fee Act / Pharmaceutical sciences / Food and Drug Administration / Pharmaceuticals policy

MEETING THE LEGAL CONDITIONS FOR USER FEES IN FY 2012 PDUFA imposes three legal conditions that FDA must satisfy before the agency can collect and spend prescription drug user fees. A summary of how each of these legal c

Add to Reading List

Source URL: www.fda.gov

Language: English
303Health / Pharmacology / Prescription Drug User Fee Act / Prescription medication / Food and Drug Administration Amendments Act / Pharmaceuticals policy / Food and Drug Administration / Pharmaceutical sciences

FY 2013 PDUFA Financial Report - Executive Summary

Add to Reading List

Source URL: www.fda.gov

Language: English
304Laboratory glassware / Vial / Polypropylene / Technology / Materials science / Dosage forms / Chemistry / Containers

Single Dose Plastic Vial Illustrated User Guide To alleviate a critical shortage of pediatric multi-trace elements and phosphate injection in the U.S. market, Fresenius Kabi is coordinating with the U.S. Food and Drug Ad

Add to Reading List

Source URL: www.fresenius-kabi.us

Language: English - Date: 2014-05-16 13:57:57
305Medicine / Health / Pharmaceuticals policy / Prescription Drug User Fee Act / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Biologic / Food and Drug Administration / Pharmaceutical sciences / Pharmacology

Microsoft Word - PDUFA FY 2011 clean[removed]doc

Add to Reading List

Source URL: www.fda.gov

Language: English
306Pharmacology / Pharmaceuticals policy / Prescription Drug User Fee Act / Food and Drug Administration / Pharmaceutical sciences / Clinical research

FY 2003 PERFORMANCE REPORT

Add to Reading List

Source URL: www.fda.gov

Language: English
307Pharmaceutical sciences / Health / Fee / Food and Drug Administration / Pharmaceuticals policy / Prescription Drug User Fee Act

Microsoft Word - PDUFA FY 2011 clean[removed]doc

Add to Reading List

Source URL: www.fda.gov

Language: English
308Pharmaceutical sciences / Drug discovery / Pharmacology / Rare Disease Day / European Organization for Rare Diseases / Rare disease / Prescription Drug User Fee Act / Orphan drug / National Organization for Rare Disorders / Health / Medicine / Pharmaceuticals policy

News from Nord An update for our members and friends Fall[removed]Alone We Are

Add to Reading List

Source URL: rarediseases.org

Language: English - Date: 2012-12-18 11:57:21
309Pharmacology / Prescription Drug User Fee Act / Clinical research / Abbreviated New Drug Application / Pharmaceutical industry / Fee / Pharmaceutical sciences / Food and Drug Administration / Pharmaceuticals policy

FY 2008 PDUFA FINANCIAL REPORT REQUIRED BY THE PRESCRIPTION DRUG USER FEE ACT AS AMENDED

Add to Reading List

Source URL: www.fda.gov

Language: English
310Health / Medicine / Pharmaceutical industry / Pharmacology / Clinical research / Prescription Drug User Fee Act / Federal Food /  Drug /  and Cosmetic Act / Abbreviated New Drug Application / Clinical trial / Food and Drug Administration / Pharmaceuticals policy / Pharmaceutical sciences

Microsoft Word - PDUFA FY 2011 clean[removed]doc

Add to Reading List

Source URL: www.fda.gov

Language: English
UPDATE