Labeling and Promotion Guidances

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• Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products - Questions and Answers; Draft Guidance for Industry
  CDER/CBER, April 2024

• 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; Guidance for Industry
  CDER/CBER, December 2023

• Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”; Guidance for Industry
  CDER/CBER, October 2023

• Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry
  CDER/CBER/CDRH/OCE/OCP, September 2023

• Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements; Guidance for Industry
  CDER/CBER/CVM, June 2023

• Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Draft Guidance for Industry
  CDER/CBER, January 2023

• Drug Products Labeled as Homeopathic; Guidance for FDA Staff and Industry
  CDER/CBER, December 2022

• Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products; Draft Guidance for Industry
  CDER/CBER, September 2022

• Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding”; Draft Guidance for Industry
  CDER/CBER, July 2022

• Instructions for Use - Patient Labeling for Human Prescription Drug and Biological Products - Content and Format; Guidance for Industry
  OCP/CDER/CBER, July 2022

• Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format; Draft Guidance for Industry
  CDER/CBER, February 2022

• Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry
  CDER/CBER, June 2021

• Geriatric Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry
  CDER/CBER, September 2020

• Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry
  CDER/CBER,  July 2020

• Child-Resistant Packaging Statements in Drug Product Labeling; Guidance for Industry
  CDER/CBER, August 2019

• Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format; Draft Guidance for Industry
  CDER/CBER, July 2019

• Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format; Draft Guidance for Industry
  OCP/CDER/CBER, July 2019

• Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice; Guidance for Industry and Review Staff
  CDER/CBER, March 2019

• Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry
  CDER/CBER, March 2019

• Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway; Guidance for Industry
  CDER/CBER, January 2019

• Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use; Guidance for Industry
  CDER/CBER/CDRH, October 2018

• Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers; Draft Guidance for Industry
  CDER/CBER, September 2018

• Labeling for Biosimilar Products; Guidance for Industry
  CDER/CBER, July 2018

• Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Draft Guidance for Industry
  CDER/CBER, July 2018

• Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers Guidance for Industry
  CDER/CBER/CDRH/CVM/OC, June 2018

• Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products -” Content and Format; Draft Guidance for Industry
  CDER/CBER, January 2018

• Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry
  CDER/CBER, December 2017

• Child-Resistant Packaging Statements in Drug Product Labeling; Draft Guidance for Industry
  CDER/CBER, August 2017

• Nonproprietary Naming of Biological Products; Guidance for Industry
  CDER/CBER, January 2017

• Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products -€” Content and Format; Guidance for Industry
  CDER/CBER, December 2016

• Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs; Draft Guidance for Industry
  CDER/CBER, August 2015

• Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products - Content and Format; Guidance for Industry -  (Small Entity Compliance Guide)
  CDER/CBER, June 2015

• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, March 2015

• Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Guidance for Industry
  CDER/CBER, December 2014

• Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CDER/CBER/CVM, December 2014

• Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements; Guidance for Industry
  CDER/CBER, February 2013

• Direct-to-Consumer Television Advertisements -- FDAAA DTC Television Ad Pre-Dissemination Review Program; Draft Guidance for Industry
  CDER/CBER, March 2012

• Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format; Guidance for Industry
  CDER/CBER, October 2011

• Presenting Risk Information in Prescription Drug and Medical Device Promotion; Draft Guidance for Industry
  CDER/CBER/CDRH/CVM, May 2009

• Indexing Structured Product Labeling; Guidance for Industry
  CDER/CBER, June 2008

• Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Guidance for Industry
  CDER/CBER, January 2006

• Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Guidance for Industry
  CDER/CBER, January 2006

• Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling
  CDER/CBER, April 2005

• Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling; Guidance for Industry
  CDER/CBER, May 2003

• Consumer-Directed Broadcast Advertisements; Guidance for Industry
  CDER/CBER/CVM, August 1999