O slideshow foi denunciado.
Utilizamos seu perfil e dados de atividades no LinkedIn para personalizar e exibir anúncios mais relevantes. Altere suas preferências de anúncios quando desejar.


2.515 visualizações

Publicada em

GUIDANCE : Centre For Drug Evaluation And Research (U.S. Requirement)

Publicada em: Direito
  • Entre para ver os comentários


  1. 1. CENTRE FOR DRUG EVALUATION AND RESEARCH (CDER) Presented By : Mahesh Ashok Marathe Department : Pharmaceutics (Sem-2) , Sinhgad college of pharmacy ,vadgaon Roll no. : 514
  2. 2. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation & Research (CDER) Center for Biologics Evaluation & Research (CBER) Center for Devices & Radiological Health (CDRH) Center for Food Safety & Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) National Center for Toxicological Research Office of the Commissioner Office of Regulatory Affairs Mission…..??
  3. 3.  CDER’s mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use.  To protect public health by promoting the safe use of marketed drugs and by helping to ensure the quality and integrity of marketed drug products.
  4. 4. • Promote public health by ensuring the availability of safe and effective drugs : Promote patient and health professional awareness of drug benefits and risks through effective communication of drug information • Protect public health by promoting the safe use of marketed drugs: Oversee drug promotion and marketing to help ensure that marketed drug labeling and advertising are truthful and not misleading • Protect public health by ensuring the quality and integrity of marketed drug products 4 FUNDAMENTAL GOALS AND OBJECTIVES
  5. 5. CURRENT CDER ACTIVITY  To oversee new drug development and review of drug marketing applications.  To oversee post-marketing drug safety, to help ensure safe use of approved medicines  To oversee drug manufacturing and quality.
  6. 6.  CDER assures that all prescription and over-the- counter drugs are safe and effective.  Efficient risk management  Provides health professionals and consumers information to use drugs appropriately and safely.(ads, communication media)  Remove barriers to innovation in drug development and to facilitate the modernization of drug manufacturing. OTHER ROLES
  7. 7. WORK OF CDER  CDER Drug Product Applications  CDER Small Business Assistance Program  Small business guide to FDA  CDER Handbook describes the Center's processes and activities  New Drug Development and Review - IND, NDA  Generic Drug Review –ANDA Over-the-Counter Drug Review Post Drug Approval Activities. Communicating with CDER Other activities
  8. 8. REGULATORY GUIDANCES 3.1 Regulatory & Scientific Guidances 3.2 Submitting Applications for New Drug Products 3.4 International Activities 3.5 CDER Policies & Procedures 3.6 Compliance Activities 3.7 Useful Resources
  9. 9. Current Guidance Agenda ..DesktopGuidance Agenda 2017_2017.02.15.pdf
  10. 10. www.fda.gov/RegulatoryInformation/Gui dances/default.htm Access on 21/2/2017 www.fda.gov/cder