Specific Audiences

Information and Activities Targeted towards Specific Audiences and Populations

Consumer & Patient Information - General Information

• CDER Handbook (Updated 5/19/99) - The CDER Handbook  describes the Center's processes and activities.
• CDER Year 2000 (Y2K) Information Page (Updated 10/19/1999).
• Consumer Education: What You Should Know About Buying and Using Drug Products
• FDA Oncology Tools  Oncology Tools contains a variety of information related to cancer and approved cancer drug therapies (3/28/2001)
• From Test Tube to Patient: Improving Health Through Human Drugs also available in unsegmented version (Posted 10/25/99)   
• Women's Health Initiatives (3/24/2000)

Consumer & Patient Information - Drug Information

• Consumer Drug Information Page -  Basic label information about new, innovator drugs approved by FDA since January 1998.
• Beef Insulin:   Frequently Asked Questions about Importing Beef Insulin for Personal Use (9/13/99).
• Cancer Liaison Program - This program was added to an existing FDA office, the Office of Special Health Issues, which was established in the late 1980's to answer questions directed to FDA by AIDS patient advocates.
• New Over-the-Counter (OTC) Drug Labeling   (3/11/99)
• Over-the-Counter Medicines: What's Right for You? (1/14/2002).  Information distributed as a public service by the U.S. Food and Drug Administration (FDA) and the Consumer Healthcare Products Association (CHPA).  (Also available as a brochure in PDF format. )
• Over-the-Counter Drug Page.  Information for Consumers and Industry about Non-Prescription Drugs.

Consumer & Patient Information - Adverse Reactions & Warnings

• Reporting Adverse Reactions and Other Problems with Products Regulated by FDA.  Consumers can play an important public health role by reporting to the U.S. Food and Drug Administration any adverse reactions or other problems with products the agency regulates.
• FDA Issues Alert about Misuse of Consumer Products Containing Gamma Hydroxybutyric Acid (GHB), Gamma Butyrolactone (GBL), and 1,4 Butanediol (BD) Letter - ; Poster - (GIF)  (Posted 7/22/99)

Freedom of Information

• CDER Freedom of Information Office Electronic Reading Room - Provides information on how to request FDA information under the Freedom of Information Act.

International Activities

• International Activities Coordinating Committee (8/25/2000)
• ICH-Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients [HTML] or [Acrobat] (Issued 7/2000, Posted 8/1/2000). To make a comment on this draft guidance, please visit the FDA Dockets page
• International Conference on Harmonization: Electronic Standards for the Transfer of Regulatory Information (Updated 10/15/1999)

Pediatrics

• Pediatric Drug Development

Small Businesses

• CDER Small Business Assistance Program. What you need to do to file an application for marketing a new drug product.  (Posted 3/6/2000) 

Spanish Speaking Audiences

• CDER Handbook Spanish Edition   (4/2/2001)
• Spanish Language Guidances (12/12/01)

Some of documents are in Portable Document Format (PDF) to retain the original format. To view or print these documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's website with full installation instructions.

FDA/Center for Drug Evaluation and Research
Last Updated: January 30, 2003
Originator: OTCOM/DML
HTML by  CSA