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IMPLEMENTATION ISSUES Industry Perspective

IMPLEMENTATION ISSUES Industry Perspective. Content Coding. Standards Will there be a depth-of-coding guideline? Or any other mechanism to ensure consistency in the depth of coding across products/companies.

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IMPLEMENTATION ISSUES Industry Perspective

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  1. IMPLEMENTATION ISSUES Industry Perspective

  2. Content Coding Standards • Will there be a depth-of-coding guideline? Or any other mechanism to ensure consistency in the depth of coding across products/companies. • How would consistency be achieved if more than the items reflected under Highlights could be coded? Coding • Instituting a nomenclature for coding may not be enough. May need additional rules. • How will SNOMED and MedDRA play together in/behind US labeling?Should human readable words be SNOMED PTs or MedDRA PTs? Lack of codability/structurability • The likelyhood that advice reaches HCPs should not depend on its codability. • Where an item cannot be coded, text should be displayed. Crisp sentence may be better than full paragraph. Content of human-readable labeling compared to computer-readable labeling • CRL should not contain more (more specific) information than HRL

  3. Content Coding (continued) “Shades of grey” and nuances (must, should, consider, particularly) • How can they be retained (SNOMED?) • If they cannot be retained, are there compensatory solutions? Lists of examples • How can they be handled? Coding compliance • What if SPLs were left uncoded or partially coded? Regulatory and legal implications. Voluntary conversion of old labels • Is non-conversion an option if “direct-from-label” decision support systems are widely used? Third party information for decision support systems • Do they have special requirements?

  4. Content Coding (continued) “Information brokers” • How will they benefit from SPL? Text to code: Quality • Can we get tools to make this process easier and more transparent? • Can we get a “code viewer” that allows us to verify that our coding is consistent with full text?

  5. General • SPL Implementation • Need realistic roll-out timelines that respect software development timelines. • When will coding for highlights be required? • How will FDA interact w/ industry – e.g. coding and changes to IG • Lifecycle issues need to be addressed so that they can be considered in the development of systems/processes • Have ballot coming – how to make decisions on comments….how to manage within RCRIM • Generic labeling • How will comparison document be affected? • Will proposed generic labeling be refused because not coded? • Could generic labeling just link to clinical content of branded label? What if generic label changes before branded label?

  6. Process • How can parallel changes be handled (e.g. CBE plus several pending PAs)? • How will CBEs be handled? • Definition of which label content to submit w/ annual report? • Will we still have to submit history of changes and current and last approved once ELIPs has all labeling in SPL (after first year) • Will industry be able to review FDA approved SPL before it is posted to NLM?(even for so-called “minor” changes?)

  7. Physicians Labeling Rule • Implementation issues – printing and paper size • FDA reviewer consistency • What is the most important information • What gets truncated due to space

  8. Implementation: Coding • What codes will be required? What code systems will be followed? • What markup is optional? What is required? • Which sections/excerpts/structured content must I code? • If I don’t put in an “optional” code, could that result in a refusal to file? • What if “more exact encoding of concepts” begins to offer competitive advantages?

  9. Implementation: Validation • What constitutes a “valid” SPL? • Valid according to schema? • Entire narrative is present? • All required elements, but not all optional elements, are present? • Some or all codes are present and point to agency-approved code systems? • Codes are congruent with narrative? • Some/all/none of the above? • What will the agency validate (in new and updated submissions), and how?

  10. Implementation: Guides & Info • When will the current IG be synchronized with the current (v2a) schema? (Needs to be before October!) • Can we create some “helper” info? • List of frequently asked questions (FAQs) • “Narrative” history to facilitate baselining newcomers to the Working Group • Can we centralize SPL information?

  11. Implementation: Submission • Given the hierarchical structure of SPL content, how will partial submissions (i.e., only changed components) be managed? • How will changes in structured content be managed? • What does a flow diagram for all submissions look like? (Start with how is an SPL submitted with an eCTD and then define the flow for every other type of submission!)

  12. Implementation: Submission • How will an SPL be delivered to the agency? What information will be packaged with it (i.e., NDA number), and how? • How will an SPL be returned to the sponsor (with comments or changes)?

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