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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (10751)	3/1/2004 3:34:08 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

And here is a repost of Harold's earlier post on the SEPR thread giving the requirements for Class 1 vs Class 2 resubmissions: Definitions of Class 1 and Class 2 from fda.gov D. Class 1 resubmitted applications are applications resubmitted after a complete response letter (or a not approvable or approvable letter) that include the following items only (or combinations of these items): 1. Final printed labeling 2. Draft labeling 3. Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information including important new adverse experiences not previously reported with the product are presented in the resubmission) 4. Stability updates to support provisional or final dating periods 5. Commitments to perform Phase 4 studies, including proposals for such studies 6. Assay validation data 7. Final release testing on the last 1-2 lots used to support approval 8. A minor reanalysis of data previously submitted to the application (determined by the agency as fitting the Class 1 category) 9. Other minor clarifying information (determined by the Agency as fitting the Class 1 category) 10. Other specific items may be added later as the Agency gains experience with the scheme and will be communicated via guidance documents to industry. E. Class 2 resubmissions are resubmissions that include any other items, including any item that would require presentation to an advisory committee. Peter