Site Index

CDER Index A-F

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

Adverse Reactions

• Adverse Events Reporting System
• AERS Electronic Submissions
• Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations
• How to Report
• Medwatch

Advisory Committee and Panel Meetings

• Human Drug Advisory Committees Web Page
• Advisory Committee Agendas
• Advisory Committee Information
• Advisory Committee Transcripts
• Calendar of Events

AIDS

• AIDSinfo with Information about Clinical Trials
• Antiretroviral HIV Drug Approvals and Pediatric Labeling Information

Analgesia Drug Information

• Analgesia and Anti-inflammatory Drug Information

Annual Reports

• Annual Adverse Drug Experience Report:  1996 or 1995
• CDER 1998 Report to the Nation: Improving Public Health Through Human Drugs
• CDER 1997 Report to the Nation: Improving Public Health Through Human Drugs

Anti-Inflammatory Drug Information

• Analgesia and Anti-inflammatory Drug Information

Approval Time Statistics: CDER Guide to Median Approval Time Statistics

Approved Drugs

• Approved Drug Products With Therapeutic Equivalence Evaluations/Orange Book
• FDA Drug Approvals List
• FDA Drug Approval Packages: New Drug Approvals or Generic Drug Approvals
• FDA Drug and Device Product Approval List: Legacy Information from February 1991 through August 1996
• New Drug Approval Reports

Arthritis Drug Drug Information

• Analgesia and Anti-inflammatory Drug Information

Awards

• Innovations Award

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

Biological Therapeutic Products

Biostatistics, see Office of Biostatistics

Botanical Drug Product Development, see Botanical Review Team

Business, Small Business Assistance

Buying Medical Products Online

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

Cancer

• Cancer Clinical Trials Listing
• Cancer Drug Approval Endpoints
• Cancer Liaison Program
• Drug Approvals for Cancer Indications
• FDA Project on Cancer Drug Approval Endpoints
• Oncology Tools

Careers

• CDER Job Opportunities
• FDA Job Openings

Cenestin Information: Synthetic Conjugated Estrogens, A Approved

Cilostazol (Pletal) Approved

Clinical Investigators

• Clinical Investigators web page
• Clinical Investigators: Disqualified/Restricted/Assurance List for Clinical Investigators
• Clinical Investigator Inspection List
• Division of Scientific Investigations web page

Clinical Trials

• Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling:  A Review of New Molecular Entities Approved 1995-1999

Combination Products Program

Compliance Activities

• Disqualified/Restricted/Assurance List for Clinical Investigators
• Drug Application Regulatory Compliance
• Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations
• Establishment Evaluation System (EES)
• Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Compressed Medical Gases

Computational Toxicology: Informatics and Computational Safety Analysis Staff (ICSAS)

Conferences

• Conferences and Workshops Sponsored by CDER
• Conference, Meeting, and Workshop Presentations by CDER Staff

Consumer Information

• Catalog of FDA Information for Consumers
• Consumer Drug Information Page
• Consumer Education: What you should know about buying and using drug products
• FDA Consumer Magazine
• FDA Consumer Special Issue - From Test Tube to Patient: 2nd edition
• FDA Consumer Special Issue - From Test Tube to Patient: 3rd edition
• Over-the-Counter Drug Page

Counterfeit Drugs

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

Directories

• CDER Key Officials
• CDER FAX Directory
• HHS Employee Phone Directory (Searchable database by agency)
• Narcotic Treatment Program Directory
• National Drug Code (NDC) Directory
• Office and Subject Home Pages
• Quick Index to General Subjects Related to Drug Regulation: 1998

Dockets

• Dockets of Pending Regulations and Petitions

Drug Approval Time Statistics

Drug Information, Division of Drug Information
     Drug Information Pathfinder
     Frequently Asked Questions About Drugs

Drug Interactions

Drug Marketing, Advertising and Communications

Drug Master Files

Drug Registration and Listing

Drug Registration Drug Registration and Listing System Instruction Booklet

Drug Safety, Office of Drug Safety 

Drug Safety, Office of Drug Safety Annual Report 2001

Drug Shortages

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

Elderly

• International Year of Older Persons

Electronic

• Electronic Reading Room
• Electronic Records; Electronic Signatures (21 CFR Part 11)
• Electronic Regulatory Submissions and Review
• Electronic Submissions through the ESTRI Gateway

Employment Opportunities

Enforcement Reports

Espaņol, Publicaciones en Espaņol

Estrogen and Estrogen with Progestin for Postmenopausal Women

Estrogens Synthetic Generic Conjugated Estrogens

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

FAQ's

• Beef Insulin: Frequently Asked Questions about Importing Beef Insulin for Personal Use

• CDER Frequently Asked Questions

• Division of Drug Drug Marketing, Advertising and Communications

• "Fen-Phen" Information (fenfluramine, phentermine, dexfenfluramine)

Federal Register

• Federal Register-FDA

• Federal Register-GPO

Flu

Influenza Antiviral Drugs and Related Information

Foreign Prescription Drugs

Forms

• FDA Forms Distribution Page

• IND Form Help: Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)

• Public Use Forms and How to Obtain Them