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                Guidance for Industry

Guidance for Industry

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          Advertising and Promotion GuidancesGuidance for Industry Advertising and Promotion Guidances
  
  	
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    PrintBrief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
	Consumer-Directed Broadcast Advertisements
	Direct-to-Consumer Television Advertisements -- FDAAA DTC Television Ad Pre-Dissemination Review Program
	CVM GFI #231 Distributor Labeling for New Animal Drugs
	Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (PDF - 95KB)
	Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices - Revised Guidance (PDF - 150KB)
	Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (PDF - 118KB)
	Industry-Supported Scientific and Educational Activites (PDF - 428KB)
	Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (PDF - 176KB)
	Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (PDF - 136KB)
	Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements
	Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 933KB)
	Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 115KB)
	Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF - 103KB)
	Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF - 302KB)
	CVM GFI #240 Proprietary Names for New Animal Drugs

                                                                                  Content current as of:
      06/27/2023Guidance for Industry

          
                        Guidance by Number
          Guidances Under Development for 2023
          Newly Added Guidances
          Withdrawn/Replaced Guidances
 
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