Resources

Government Sources

• FDA Homepage: Links or all FDA offices. (FDA.org)
• FDA CBER:Describes recent biological approvals
• FDA CADER:Describes new drug approvals, NDA review process, links to CDER’s gopher, which provides access to a variety of directories, including policies and procedures, DMFs, Human Drug CGMP notes, approved drug products, and FDA phone/fax numbers
• GPO Access: The Government printing offices home page
• NIH Small Business Funding Opportunities
• National Center for Biotechnology Information (NCBI)

Professional Organization

• DIA: Drug Information Association
• Regulatory Affairs Professional Society (RAPS) Home page:
• BIO online:The Biotechnology Industry Organization
• GPO Access: The Government printing offices home page
• AAPS The American Association of Pharmaceutical Scientists

Industry-Documents and other information

• DIA: Drug Information Association
• IDRAC: The world's most comprehensive pharmaceutical regulatory affairs database
• HIS Health information: HIS Health Information offers the most comprehensive set of pharmaceutical and medical device manufacturing regulation and standards available from one source

Industry –Biologics

• BioSpace.com: The Global Hubsite for Life Sciences
• BioSpaceIndustry Links:
• BioWorld.Online:The worldwide Biotechnology News and Information Source
• Medscape Molecular Medicine:

Industry Pharmaceuticals

• Pharmatech’s Home page
• Pharmaceuticals Education & Research Institute

Industry-Devices

• Promega’s Home Page
• CLIA:Clinical Laboratory Improvement Amendments
• MMA:Medical Marketing Association (Devices)

Disease Specific Organizations

• AAD:American Academy of Dermatology
• AHA:American Heart Association
• ACS:American Cancer Society
• ASGT:American Society for Gene Therapy
• ASCO:American Society of Clinical Oncology
• CFF:Cystic Fibrosis Foundation