FDA

• Food and Drug Administration Home Page

• FDA OPDP Warning

• FDA Untitled Letters

• How to Make a FOI Request

• OPDP Home Page

• OPDP Laws, Regulations, Guidances and Enforcement Actions

• OPDP Research

• FDA Bad Ad Program

FEDERAL FOOD, DRUG, AND COSMETIC ACT

• FD&C Act Chapter V: Drugs and Devices

CODE OF FEDERAL REGULATIONS

• 21 CFR 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices

• 21 CFR 200 - General (Secs. 5, 7, & 200)

• 21 CFR 201 - Labeling Secs. 10, 100, & 200)

• 21 CFR 202 - Prescription Drug Advertising

• 21 CFR 312 - Investigational New Drug Application (Sec. 7)

• 21 CFR 314 - Applications to Market New Drug or Antibiotic (Secs. 81, 550, & 560)

ADDITIONAL CODES AND GUIDANCES

• Accreditation Council on Continuing Medical Education

• Pharmaceutical Research and Manufacturers of America (PhRMA)

• Phrma DTC Guiding Principles

• PhRMA Codes and Guidelines

COMPLIANCE RESOURCES

• Office of the Inspector General OIG Compliance Guide for Pharmaceutical Marketers

• Pharmaceutical Corporate Integrity Agreements - DOJ site

• HEAT Provider Compliance Training Videos

INTERNATIONAL RESOURCES

• Global Comparison of Pharmaceutical Codes of Marketing Practice

• EFPIA HCP Code

• European Social Media Guidance

• Advertising of medicines: The legislative framework

• UK CAP Code

• Prescription Medicines Code of Practice Authority

• MHRA – Medicines and Healthcare Products Regulatory Agency

• UK Advertising Codes

• Australian Pharmaceutical Manufacturers Association Code of Conduct

• Medicines Australia - Code of Conduct

• Therapeutic Goods Advertising

• PAAB - Canadian Regulatory Requirements

• Health Canada Advertising Regulation

• The Blue Guide: Advertising and Promotion of Medicines in the UK

• Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)

UPCOMING CONFERENCES

• DIA Advertising and Promotion Regulatory Affairs Conference (03/8/22-03/9/22 Washington DC)