Updated Prescription Drug Labeling Resources

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . Updated Prescription Drug Labeling Resources FDA has updated its labeling resources for human prescription drugs, for industry staff who develop human prescription drug labeling. Human prescription drug labeling (1) contains a summary of the essential scientific information needed for the safe and effective use of the drug; and (2) includes the Prescribing Information, FDA-approved patient labeling (Medication Guides, Patient Package Inserts, and/or Instructions for Use), and/or carton and container labeling. Labeling resource topics include: Patient Labeling Resources Carton and Container Labeling Resources Selection of Appropriate SPL Codes for Human Prescription Drug Labeling Generic Drugs-Specific Labeling Resources Biological Products-Specific Labeling Resources Prescription Drug Labeling Contact Information Prescribing Information Resources Healthcare professionals can visit Frequently Asked Questions about Labeling for Prescription Medicines. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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