Information and Activities: Specific Audiences and Populations

Contents On This Page

• Consumer & Patient Information - General Information
• Consumer & Patient Information - Drug Information
• Consumer & Patient Information - Adverse Reactions & Warnings
• Freedom of Information
• International Activities
• Pediatrics
• Small Businesses
• Spanish Speaking Audiences

Consumer & Patient Information - General Information

• CDER Handbook - The CDER Handbook  describes the Center's processes and activities.
• Consumer Education: What You Need to Know to Use Medicine Safely
• FDA Oncology Tools  Oncology Tools contains a variety of information related to cancer and approved cancer drug therapies
• From Test Tube to Patient: Improving Health Through Human Drugs
• Women's Health Initiatives

Consumer & Patient Information - Drug Information

• Consumer Drug Information Page -  Basic label information about new, innovator drugs approved by FDA since January 1998.
• 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
• Over-the-Counter Medicines: What's Right for You? .  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

• 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

• U.S. FDA Considerations: Discussion by National Regulatory Authorities with World Health Organization (WHO) On Possible International Non-proprietary Name (INN) Policies for Biosimilars
• International Activities Coordinating Committee
• 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 To make a comment on this draft guidance, please visit the FDA Dockets page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 [external link]

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.

Spanish Speaking Audiences

• CDER Handbook Spanish Edition  
• Spanish Language Guidances

Back to Top     Back to CDER Homepage

PDF requires the free Adobe Acrobat Reader

Last Updated: October 6, 2006