| 2005N-0403 | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs | ||||||||||||||||||||||
| FDA Comment Number : | EC7 | ||||||||||||||||||||||
| Submitter : | Dr. FRANCESCA LOTTO | Date & Time: | 12/01/2006 09:12:04 | ||||||||||||||||||||
| Organization : | QA | ||||||||||||||||||||||
| Category : | Private Industry | ||||||||||||||||||||||
| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| Re: [DOCKET No. 2005N-0403]
RIN 0910-AA49 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drug, Concerning paragraph ? 207.57 "What are the requirements for reviewing and updating listing information?", it is stated that manufacturers must review and update their listing information each June and December of every year for five specific cases. In particular, case 5), if no changes have occurred since the last review and update, certification that no changes have occurred must be done. Our Comment: The way to perform this certification shoul be clarified. Is it a single official letter covering all the NDC listings and stating that are all still current adequate ? Or must Form 2657 for each single NDC listing be completed indicating that NO CHANGE OCCURRED? Moreover, due to the fact that no changes occured, is mandatory to certify this twice per year ? Our company has over 50 NDC listings and it will be easy and quick to do this certification by a single letter in spite of filling in Form 2657 for each single listing and perform this activity once during the year (December for example), if no changes occured. Thank you and best regards Dr. FRANCESCA LOTTO QA & REGULATORY AFFAIRS DIRECTOR francesca.lotto@fisvi.com F.I.S. - FABBRICA ITALIANA SINTETICI SPA VIALE MILANO NR. 26 36075 ALTE DI MONTECCHIO MAGGIORE | |||||||||||||||||||||||
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