Drug user

Results: 1369



#Item
991Pharmaceuticals policy / Food law / Prescription Drug User Fee Act / Pharmacology / Federal Food /  Drug /  and Cosmetic Act / Mammography Quality Standards Act / Abbreviated New Drug Application / Mammography / Medical device / Medicine / Food and Drug Administration / Health

USER FEES -- $31,320,000 User Fee Overview PDUFA: + $20,938,000 This budget requests a $31,320,000

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Source URL: www.fda.gov

Language: English
992Health / Pharmaceutical industry / Medical equipment / Clinical research / Validity / Validation / Medical device / Design controls / Federal Food /  Drug /  and Cosmetic Act / Medicine / Food and Drug Administration / Technology

Guidance for Industry and FDA Staff Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed SingleUse Medical Devices

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Source URL: www.fda.gov

Language: English
993Pharmaceutical sciences / Premarket approval / Center for Devices and Radiological Health / Medical device / Investigational Device Exemption / New Drug Application / Prescription Drug User Fee Act / Food and Drug Administration / Medicine / Health

[removed]Page 1 MDUFA Performance Goals and Procedures ................................................................ 3 I. Process Improvements............................................................................

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Source URL: www.fda.gov

Language: English
994Drug control law / Corruption / Crime / Counter-terrorism / United Nations Office on Drugs and Crime / Convention against Transnational Organized Crime / Transnational organized crime / United Nations Convention against Corruption / Political corruption / Law / United Nations / Human trafficking

The Omnibus survey software is an efficient, interactive and user friendly tool conceived to simplify reporting obligations vis-à-vis the United Nations Convention against Transnational Organized Crime and the Protocols

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Source URL: www.unodc.org

Language: English - Date: 2010-10-04 13:03:40
995Pharmaceutical sciences / Pharmacology / Adverse event / Clinical research / Pharmaceutical industry / MedWatch / Medical device / Center for Devices and Radiological Health / Unique Device Identification / Food and Drug Administration / Medicine / Health

FINAL REPORT OF A STUDY TO EVALUATE THE FEASIBILITY AND EFFECTIVENESS OF A SENTINEL REPORTING SYSTEM FOR ADVERSE EVENT REPORTING OF MEDICAL DEVICE USE IN USER FACILITIES PREPARED UNDER CONTRACT # [removed]

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Source URL: www.fda.gov

Language: English
996Technology / Investigational Device Exemption / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Medical device / Center for Devices and Radiological Health / Title 21 of the Code of Federal Regulations / Clinical trial / Humanitarian Device Exemption / Food and Drug Administration / Medicine / Health

Assessing User Fees; PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions Bundling Multiple Devices in a Single Application and Fees for Combinations PRoducts; Guidance for Industry and F

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Source URL: www.fda.gov

Language: English
997Technology / Investigational Device Exemption / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Medical device / Center for Devices and Radiological Health / Title 21 of the Code of Federal Regulations / Clinical trial / Humanitarian Device Exemption / Food and Drug Administration / Medicine / Health

Assessing User Fees; PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions Bundling Multiple Devices in a Single Application and Fees for Combinations PRoducts; Guidance for Industry and F

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Source URL: www.fda.gov

Language: English
998Health / Clinical research / Pharmacology / Clinical pharmacology / United States Public Health Service / Prescription Drug User Fee Act / Norfloxacin / Orphan drug / Unique Device Identification / Pharmaceuticals policy / Food and Drug Administration / Pharmaceutical sciences

Federal Register / Vol. 79, No[removed]Tuesday, July 8, [removed]Notices strengthen regulatory capacity throughout the Americas in ways that provide benefit and contribution to the FDA regulatory and public health mission.

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Source URL: www.gpo.gov

Language: English - Date: 2014-07-08 00:12:47
999Medicine / Pharmacology / Pharmaceuticals policy / Prescription Drug User Fee Act / FDA Fast Track Development Program / Fibromyalgia / Food and Drug Administration / Health / Pharmaceutical sciences

Patient‐Focused Drug Development Public Meeting Public Meeting Theresa M. Mullin, Ph.D. Associate Director for Planning and Informatics FDA Center for Drug Evaluation and Research

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Source URL: www.fda.gov

Language: English
1000Clinical research / Pharmaceuticals policy / Clinical pharmacology / United States Public Health Service / Prescription Drug User Fee Act / Critical Path Institute / Center for Drug Evaluation and Research / Food and Drug Administration / Pharmaceutical sciences / Pharmacology

1 U.S. FOOD AND DRUG ADMINISTRATION + + + + + PATIENT-FOCUSED DRUG DEVELOPMENT + + + + +

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Source URL: www.fda.gov

Language: English
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