United States Prescribing Information (USPI) sets out the agreed usage of the drug. It provides information on usage for healthcare professionals, also known as the drug product label, prescription drug labeling, product insert, package insert, professional label, direction circular or package circular. It is an intrinsic part of the application for marketing authorization of a new drug or medicine within the United States. The USPI is typically the last step of the drug development process. It is a key mechanism to communicate to prescribers such benefit-risk information in the form of codified claims of clinical efficacy, measures of safety and risk management, and guidelines on appropriate dosage.
Submissions to the FDA
FDA's Prescription Drug Labeling Resources website provides over 150 labeling resources for the Prescribing Information, FDA-approved patient labeling, and/or carton and container labeling for human prescription drugs, including biological products (including over 50 guidances with labeling content)
PI Resources
- Labeling regulations
- Guidances
- Presentations
- Templates
- Format Tools
- Databases
- Patient Labeling (Instructions for Use, Medication Guides, and Patient Information)
- carton labeling and container labeling
- Additional labeling resources
In an effort to help clients meet their Regulatory requirements, MedTrans provides the service of converting current labeling content into the required Structured Labeling Format (SPL) format, adhering to Physician Labeling Rule (PLR) Compliance and Drug Registration and Listing.
Our Expertise
- New Chemical Entity (NCE)
- Physician Labeling Rule (PLR) Conversions
- Pregnancy Lactation Labeling Rule (PLLR) Conversions
- Structured Product Labeling (SPL)
- Generic Molecules
- Reference Listed Drug (RLD) label change monitoring
- Annotated PI and Carton Labels
- Side by Side Label Comparison- USPI, USPPI, MG
- Clean PI and Carton Labels
- Label Change History
- SPL Conversion
- Biologics & Biosimilar Products
- Labeling/Tracking
- Clinical Data for Indications
- Overall Risk/Benefit Profile
Features
- High Quality-- Ensure the rigor and correctness of the translation.
- Elite Translation-- Proficient translators and responsible proofreading
- Proper Manuscript Management
MedTrans understands the intent and needs of the SmPC documents translation. We would like to help your teams produce quality documents from your clinical program to submission dossier, and can hit the ground running as soon as you have the Agency's approval.