Composing a Company Core Data Sheet (CCDS) is one of the toughest challenges facing drugmakers today. Are YOUR CCDS-writing skills in need of a brush-up?
Here’s the help you need.
The CCDS is the prime reference document for every one of your drugs or biologics — the central document regulators and resellers rely on to label and manage the drug’s use.
Approved indications ... dosing requirements ... methods of administration ... concerns of special patient populations ... packaging and storage requirements and limitations ... incompatibilities and pharmacological properties — all must be in the CCDS, plus safety information.
And there’s more. You must update each CCDS to reflect the drug’s evolution. New indications, dosing changes, changes in handling procedures, safety concerns — all those factors and more must be added in on a regular basis.
What’s the best way to correctly handle these essential documents? Make sure you’re up to speed with the authoritative report from FDAnews: Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS - 2014.
In this newly updated 2014 edition there is an expanded section on company core safety information (CCSI), including:
In addition, this guide spells out how to draft and maintain a CCDS for each of your products — a start-to-finish explanation that includes:
Perfecting Your Company Core Data Sheets answers your toughest questions:
With Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS - 2014, you'll have the tools to create and maintain a CCDS that will withstand regulatory scrutiny, and you’ll avoid the unnecessary extra work that comes from assuming what’s the best way to write them.
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