CDER Index G-L

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Generic Drugs

• Consumer Education: Generic Drugs
• Generic Drug Approvals
  • 1998-2004
  • Drugs@FDA
• Office of Generic Drugs
• Therapeutic Equivalence of Generic Drugs
  • Letter to Health Practitioners
  • Response to National Association of Boards of Pharmacy

Genomics

• Genomics at FDA

Good Manufacturing Practices -- see Current Good Manufacturing Practices (cGMP)

Guidance Documents

• CDER Guidance Documents
• CDER List of Guidance Documents
• Compressed Medical Gases Guidance Documents
• FDA Guidance Documents for Regulated Industry

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Handbooks

• Be an Active Member of Your Health Care Team
• CDER Handbook
• CDER Handbook (Spanish Edition)
• The Leveraging Handbook: An Agency Resource for Effective Collaborations
  • [HTML]
  • [PDF]

Hepatotoxicity

• Drug-Induced Liver Toxicity

History

• CDER
• FDA
• FDA Centennial: 1906-2006

Harmonization

• International Conference on Harmonization: Electronic Standards for the Transfer of Regulatory Information (ICH-ESTRI)
• International Conference on Harmonization: Guidance Documents

Homepages (Offices and Divisions)

Hormone Replacement Therapy -- see Estrogen

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Imaging, Medical -- see Medical Imaging and Drug Development

Importing Prescription Drugs

Inactive Ingredient Database

Influenza

• Importing Prescription Drugs
• Influenza (Flu) Antiviral Drugs and Related Information

Informatics and Computational Safety Analysis Staff (ICSAS)

Information Management

International Activities

• CDER Forum for International Regulatory Authorities

International Affairs

Investigational New Drug Applications (INDs)

• Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs): Forms FDA 1571 and FDA 1572

Investigations, Scientific

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Job Opportunties

• Career Opportunities at CDER
• FDA Job Openings

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Labeling

• Class Labeling for Intranasal and Orally Inhaled Corticosteroid Containing Drug Products Regarding the Potential for Growth Suppression in Children
• Labeling Changes Related to Drug Safety
• Labeling Guidance Documents
• Labeling Review Branch
• New Requirements for Prescribing Information
• Patient Labeling and Risk Communication (includes Medication Guides)

Laws / Legal / Regulatory

• Code of Federal Regulation (CFR) Title 21 (revised April 1, 2005)
• Compilation of Laws Enforced by The US Food and Drug Administration and Related Statutes
• FDA Enforcement Report Index
• Federal Food, Drug and Cosmetic Act
• Laws Enforced by the FDA and Related Statutes

The Leveraging Handbook: An Agency Resource for Effective Collaborations

• [HTML]

• [PDF]

Lindane Shampoo and Lotion

Liver Disease

• Drug-Induced Liver Toxicity

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Date created: January 31, 2007

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