Upload File

center for drug evaluation and research approval

  • Home
  • Documents
  • CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
26

Upload: haphuc

Post on 31-Dec-2016

220 views

Category:

Documents


4 download

Report

TRANSCRIPT

Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 8: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 9: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 10: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 11: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 12: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 13: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 14: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 15: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 16: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 17: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 18: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 19: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 20: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 21: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 22: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 23: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 24: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 25: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL
Page 26: CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL

The New Drug Approval Process

CENTER FOR DRUG EVALUATION AND RESEARCH · 10503) in the drug product. These include studies conducted to fulfill post-approval commitments stated in the Agency’s approval letter

Embracing Innovation in the Animal Drug Approval Process Presentation5...Embracing Innovation in the Animal Drug Approval Process Steven Vaughn, DVM Office of New Animal Drug Evaluation

CENTER FOR DRUG EVALUATION AND RESEARCH Approval …CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: NDA 20-031/S-052 CONTENTS Reviews / Information Included in this NDA

HISTORY AND VARIOUS PHASES OF DRUG DEVELOPMENT AND DRUG APPROVAL PROCESS

20-690/8011 - Food and Drug AdministrationCENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 20-690/8011 CONTENTS Reviews / Information Included in this NDA Review. Approval

EUROPEAN UNION DRUG APPROVAL: Overview of New …€¦ · April 1996 EUROPEAN UNION DRUG APPROVAL Overview of New European Medicines Evaluation Agency and Approval Process GOA years

Historical aspects of drug approval process

Drug Approval System of Japan

CENTER FOR DRUG EVALUATION AND RESEARCH Approval … · Approval Package for: APPLICATION NUMBER: NDA 022410/S-014 ... Sublingual Film manufactured in the ... The left margin should

Drug Approval System of Chile

FDA drug approval and its relation to a …Journal of Finance and Accountancy Volume 24 FDA drug approval, Page 1 FDA drug approval and its relation to a pharmaceutical company’s

Drug approval and promotion in the UNITED STATES - doh · Drug approval and promotion in the UNITED STATES

Preliminary Agenda - APCDG · WORKSHOP 5: Drug approval and access to patients 9.00 – 9.20 Regulatory approval & Market access Drug approval and market access: Can patients make

Guidance for New Drug Approval-23.07

Approval Package for - Food and Drug Administration FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: NDA 19-872/S-029 Name: Tylenol 8-Hour (650 mg acetaminophen)

Challenges of Abuse Liability Evaluation During Drug ...Challenges of Abuse Liability Evaluation During Drug Development and Approval Of New Compounds Richard H. Alper, PhD Global

FDA Drug Approval Process

Drug approval system of Uzbekistan

Drug Approval System of Australia

Drug approval process&

EUROPEAN UNION DRUG APPROVAL: Overview of … 1996 EUROPEAN UNION DRUG APPROVAL Overview of New European Medicines Evaluation Agency and Approval Process GOA years 1921 - 1996 GAO/HEHS-96-71

Drug Approval Strategies

Investigational Drugs Drug Laws, Drug Approval Process

CENTER FOR DRUG EVALUATION AND … FOR DRUG EVALUATION AND RESEARCH Approval Package ... proposed for consistency with company’s core data sheet and ... Drug Evaluation and Research

HBM New Drug Approval Report 2013

FDA Guidelines for Drug Development & Approval

CENTER FOR DRUG EVALUATION AND RESEARCH · 2018. 6. 21. · CENTER FOR DRUG EVALUATION AND RESEARCH 761079Orig1s000 CONTENTS Reviews / Information Included in this NDA Review. Approval

CENTER FOR DRUG EVALUATION AND RESEARCH … Prior Approval supplemental new drug application ... CENTER FOR DRUG EVALUATION AND RESEARCH ... Product Quality Microbiology Data Sheet

Herceptin® (trastuzumab), - Food and Drug Administration · PDF fileCENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: BLA 103792/5275 Trade

New Drug Development and Approval Process

FDA Drug Approval Regulations & Safety

Pediatric Assessment in Drug Development and … Assessment in Drug Development and Regulatory Approval in Japan Mayumi SHIKANO, Ph.D. Associate Director, Center for Product Evaluation

co lo r fu ll and Approval - PhRMA...Modernizing Drug Discovery, Development and Approval fu ll co lo r bl ac k white Encourage Use of 21st Century Tools for Drug Evaluation, Review

Approval Package for - Food and Drug Administration · Center for Drug Evaluation and Research Division of Drug Marketing, Advertising, and Communications 5901-B Ammendale Road Beltsville,