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Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda (Drugs@FDA)
Index to Drug-Specific Information
Chronological List of Approvals
Drug Approvals 1996-2002
Drug Approvals Prior to1996
New Drugs Approved for Cancer
Drug Approval Statistics

Drugs and Diseases
MedlinePlus (National Library of Medicine)

Clinical Trials
Good Clinical Practice
Participating in Clinical Trials (NIH)
Cancer Clinical Trials (NIH)
Access to Unapproved Drugs
Office of Special Health Issues

Generic Drugs
Office of Generic Drugs Web page
Orange Book
Paragraph IV Patent Certifications
First-time Generics

Drug Availability
Drug Shortages
Drug Recalls

Drug Safety
Public Health Advisories
Medication Guides
MedWatch - Safety Information and Adverse Event Reporting
Consumer Education: What You Need to Know to Use Medicine Safely

Drug Identification
DDI Drug ID service
National Drug Code Directory 

CDER 2007 Update: Improving Public Health Through Human Drugs
CDER Report to the Nation Archives
From Test Tube to Patient

Imports and Buying Drugs on the Internet
FDA Import Policy
Importing Prescription Drugs
Buying Medicines Online/Internet

Counterfeit Drugs
Reporting Illegal Sales of Medical   Products on the Internet
Federal Trade Commission Consumer Complaint Form

Dietary Supplements

Over-the-Counter (OTC) Medicines
OTC Home Page
OTC Rulemaking
Drug Registration and Listing

Drug Review Process
CDER Handbook
FDA Consumer Articles
Drug Approval Application Process
Small Business Assistance

Drug Development
Drug Applications
Pre-IND Consultation Contacts
Request for Single Patient or Emergency Use IND
CDER Organization Chart
Guidance for Industry
Guidance for Institutional Review
   Boards (IRBs), Clinical Investigators,
   and Sponsors
Good Manufacturing Practice Regulations
Good Clinical Practice Questions and
Small Business Assistance
Code of Federal Regulations
United States Pharmacopeia

Additional General Drug Information Links

Hot Topics at CDER
Accutane and iPLEDGE
Antidepressant Warnings
Anti-epileptic drugs
COX-2 Inhibitors and NSAIDs
 (including Bextra, Celebrex, and Vioxx)
Long Acting Beta Agonist Inhalers
(Serevent Diskus, Advair Diskus, and Foradil)
Mifeprex (RU-486)
New Requirements for Prescribing Information
Plan B
Unapproved Drug Products
Drug Specific Safety Information
Additional Specific Drug Info

Links to State Boards and Organizations
State Boards of Pharmacy
Federation of State Medical Boards
American Medical Association
American Society of Health-Systems Pharmacists

Top Drug Information Questions
Frequently Asked Questions of DDI Staff
Frequently Asked Questions to CDER
Frequently Requested FDA Telephone Numbers

Still can’t find the answer?
Visit the DDI home page.
Contact CDER’s Division of Drug Information.

1-888 463-6332 or (301) 796-3400

Division of Drug Information
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Created: April 20, 2004, Updated: August 4, 2008

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