FMD K&L can help you prepare the company core data sheet (CCDS), which FDAnews calls “one of the toughest challenges facing drugmakers today”
We offer a full range of professional services to centrally manage the entire label lifecycle, from initial design and review to obsolescence.
- Development of the Investigational Brochure (core safety information), target product profiles & target labeling
- Writing & design of effective, defensible labeling content & format implementation before filing
- Assistance with regulatory requests to correct noncompliant proposed labeling content
- Writing or updating labeling documents including CCDSs
- Creation of:
- A labeling decision-making structure for products under development & post-marketing labeling changes
- The structure & features of CCDSs & guidance in populating implementable CCDSs
- Labeling project management systems to manage requests, document decisions, track implementation & integrate product knowledge bases
- Labeling databases & document management systems for tracking & auditing systems
Regulations for required product labeling vary widely from region to region.
- Approved indications
- Dosing requirements
- Methods of administration
- Concerns of special patient populations
- Packaging & storage requirements & limitations
- Incompatibilities and pharmacological properties
- Safety information
After the product launches, each CCDS must be updated to reflect the product’s evolution.
- New indications
- Changes in dosage & administration
- Changes in handling procedures
- Safety concerns
Our service streamlines change requests to local labeling documents and to the CCDS. We specialize in identifying labeling prospects in an existing portfolio and we can provide strategic CCDS consulting.
- Comparative analysis of local label content
- Preparation of a label comparison chart showing similarities & differences
- Evaluation of similarities & differences for inclusion in a CCDS
- Provision of guidance on additional CCDS elements required to meet regulatory requirements in all desired markets
- Creation of a draft CCDS & updates
FMD K&L professionals are highly experienced in developing and reviewing all labeling documentation for India, US, EU, and rest of world (ROW) markets, in full accordance with current legislation.
- Product naming services
- Summary of Product Characteristics (SmPC)
- Patient leaflets
- Inner & outer package labels
- Mockups per blue-box requirements
- Product Information File (PIF)
We also provide XML Structured Product Labeling (SPL) for the US. SPL is an XML standard used by FDA to facilitate reliable communication of drug labeling data among groups including hospitals, doctors, pharmacies, and the general public. SPL is both an HL7- and ANSI-approved standard.