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

---

Acronyms and Abbreviations

Adverse Reactions

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

Advisory Committee and Panel Meetings

• Advisory Commitee
  • Agendas
  • Information
  • Transcripts
• Calendar of FDA Advisory Committee Meetings
• Human Drug Advisory Committees

AIDS

• AIDSinfo - HIV / AIDS Information
• 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 | 1995
• CDER Report to the Nation: Improving Public Health Through Human Drugs: 1998 | 1997
• Office of Drug Safety Annual Report: 2001

Anti-Inflammatory Drug Information

• Analgesia and Anti-inflammatory Drug Information

Approval Time Statistics

• CDER Guide to Median Approval Time Statistics

Approved Drugs

• Additions/Deletions for Prescription and OTC Drug Product Lists (1996 - present)
• Approved Drug Products With Therapeutic Equivalence Evaluations / Orange Book
• CDER Drug and Biologic Approval Reports
• Drug Approval Packages
  • New Drug Approvals
    • 1998-2004
    • 1997
    • 1996 and earlier
    • Drugs@FDA
  • Generic Drug Approvals
• Drugs@FDA
• FDA Drug Approvals List (July 1996 - August 2002)
• FDA Drug and Device Product Approvals (February 1991 - August 1996)
• Orange Book

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 Medicines and 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

• Approved Oncology Drugs
• Cancer Clinical Trials Listing
• Cancer Drug Approval Endpoints
• Cancer Liaison Program
• FDA Project on Cancer Drug Approval Endpoints
• Office of Oncology Drug Products Web Site

Careers -- see Job Opportunties

Cenestin Information: Synthetic Conjugated Estrogens, A Approved

Centennial, FDA

FDA Centennial at CDER

Cilostazol (Pletal) Approved

Clinical Investigators

• Disqualified / Restricted / Assurances List for Clinical Investigators
• Division of Scientific Investigations
• Information for Clinical Investigators
• Investigational Human Drugs: Clinical Investigator Inspection List (CLIIL)

Clinical Trials

• AIDSinfo - HIV / AIDS Clinical Trials
• ClinicalTrials.gov
• Office of Special Health Issues
  • Clinical Trials
  • Patient Involvement With Life Threatening Disease
• Good Clinical Practice in FDA-Regulated Clinical Trials
• Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling:  A Review of New Molecular Entities Approved 1995-1999

Office of Combination Products

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
  • 2006 | 2005 | 2004 | 2003 | 2002
  • 2001 | 2000 | 1999 | 1998 | 1997

Compressed Medical Gases

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

Conferences

• CDER Presentations
• CDER Sponsored Workshops and Meetings

Consumer Information

• Catalog of FDA Information for Consumers
• Consumer Education: What You Need to Know to Use Medicine Safely
• FDA Consumer Magazine
• From Test Tube To Patient: Protecting America's Health Through Human Drugs (FDA Consumer Special Issue)
• Index to Drug-Specific Information
• Office of Nonprescription Products

Combating Counterfeit Drugs

COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Critical Path to New Medical Products

Current Good Manufacturing Practices (cGMP)

• Good Manufacturing Practices: Human Drug cGMP Notes
• Pharmaceutical cGMPs: A Risk-Based Approach
• Pharmaceutical cGMPs: A Risk-Based Approach; Final Report
• Questions and Answers on Current Good Manufacturing Practices (cGMP) for 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

---

Databases

• Inactive Ingredient Database

Directories

• CDER Key Officials
• CDER Offices and Divisions
• CDER Organization Charts and Directories
• CDER Reference Guide
• HHS Employee Phone Directory
• National Drug Code (NDC) Directory

Disasters

Dockets

• Dockets Management

Drug Approval Time Statistics

Drug Development and Drug Interactions

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

Drug Interactions: What You Should Know

Drug Marketing, Advertising and Communications

Drug Master Files

Drug Registration and Listing

Drug Registration and Listing Instructions

Office of Surveillance and Epidemiology

Office of Drug Safety Annual Report 2001

Drug Shortages

Drugs@FDA

---

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

• FDA Information for Seniors

Electronic

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

Employment Opportunities

Enforcement Report Index

Espa?ol, Publicaciones en Espa?ol

Estrogen

• Estrogen and Estrogen with Progestin for Postmenopausal Women
• Estrogens Synthetic Generic Conjugated Estrogens

Exocrine Pancreatic Insufficiency Drug Products -- see Pancreatic Insufficiency Drug Products

---

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

---

FAQs

• CDER Frequently Asked Questions
• Division of Drug Drug Marketing, Advertising and Communications
• Frequently Asked Questions About Drugs
• Importing Beef Insulin for Personal Use
• Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs
• "Fen-Phen" Information (fenfluramine, phentermine, dexfenfluramine)

Federal Register

• Federal Register-FDA
• Federal Register-GPO

Flu -- see Influenza

Follow-On Proteins

• Regulatory and Scientific Issues Related to Developing Follow-On Protein Products

Foreign Prescription Drugs

• Importing Prescription Drugs

Forms

• FDA Electronic Forms - Numerical Listing
• Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs): Forms FDA 1571 and FDA 1572
• Public Use Forms and How to Obtain Them

Freedom of Information Act (FOIA)

• Electronic Reading Room

---