Handout
Selected FDA Guidance Documents
Drug Advertsing: Glossary of Terms www.fda.gov/drugs/prescription-drug-advertising/drug-advertising-glossary-terms
Prescribing Information Resources for Industry
www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/prescribing-information-resources
Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements.
www.fda.gov/files/drugs/published/Labeling-for-Human-Prescription-Drug-and-Biological-Products---Implementing-the-PLR-
Content-and-Format-Requirements.pdf
FDA Department of Health and Human Services- Subchapter C- Drugs: General; Part 201- Labeling
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201
Patient Labeling Resources For Industry
www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-labeling-resources
Patient Medication Information (PMI)
www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-medication-information-pmi
www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ cm072392.pdf
FDA PI website: https://www.accessdata.fda.gov/scripts/cder/daf/
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and
Promotional Labeling for Prescription Drugs www.fda.gov/media/70768/download
Labeling Requirements –Misbranding Sections 502(a) and 201(n)
www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-
misbranding#:~:text=Section%20502(a)%20declares%20that,or%20misleading%20in%20any%20particular
Presenting Risk Information in Prescription Drug and Medical Device Promotion. www.fda.gov/media/76269/download
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared
Medical Products. Questions and Answers Guidance for Industry. www.fda.gov/media/173172/download
www.fda.gov/drugs/prescription-drug-advertising/product-claim-ad-correct
www.fda.gov/drugs/prescription-drug-advertising/reminder-ad-correct
www.fda.gov/drugs/prescription-drug-advertising/correct-help-seeking-ad
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral
Manner in Advertisements in Television and Radio Format Final Rule, Questions and Answers.
www.fda.gov/media/175074/download
Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.
www.fda.gov/media/88545/download
Guidance for Industry Internet/Social Media Platforms with Character Space Limitations. www.fda.gov/media/88551/download
For Industry: Using Social Media www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/industry-using-social-media
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared
Medical Products Questions and Answers
www.fda.gov/regulatory-information/search-fda-guidance-documents/communications-firms-health-care-providers-regarding-
scientific-information-unapproved-uses
Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers
www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-and-device-manufacturer-communications-payors-
formulary-committees-and-similar-entities
Labeling Requirements – Misbranding
www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-misbranding
Mislabeling vs. Misbranding: A Practical Guide with Examples February 22, 2023 www.thelangelfirm.com/debt-collection-defense-
blog/2023/february/mislabeling-vs-misbranding-a-practical-guide-wit/
The Office of Prescription Drug Promotion (OPDP) www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-
prescription-drug-promotion-opdp
OPDP Regulatory Information and Guidance Documents. www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-
regulatory-information#Guidances
Warning Letters. www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-
activities/warning-letters
QSYMIA FDA Warning Letter Example. www.fda.gov/media/126604/download; www.fda.gov/media/126605/download
FDA’s ‘Bad Ad’ Program Encourages HCPs to Report False or Misleading Prescription Drug Promotion.www.fda.gov/drugs/office-
prescription-drug-promotion/fdas-bad-ad-program-encourages-hcps-report-false-or-misleading-prescription-drug
promotion#:~:text=The%20FDA%20“Bad%20Ad”%20Program&text=The%20program%20encourages%20HCPs%20to,to%20BadAd%
40fda.gov.
PhRMA Code: Interactions with Healthcare Professionals.
phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA-Code---Final.pdf
Presenting Risk Information in Prescription Drug and Medical Device Promotion. https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/presenting-risk-information-prescription-drug-and-medical-device-promotion
Consumer-Directed Broadcast Advertisements https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/consumer-directed-broadcast-advertisements
Direct-to-Consumer Prescription Drug Advertisements: https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/direct-consumer-prescription-drug-advertisements-presentation-major-statement-clear-conspicuous
