generics+--+8-5-08+minutes


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SPL Process Team - Generic Drugs Subgroup Meeting** **Aug 5, 2008** ** Minutes ** -
 * 3pm **** EDST **
 * Proposed agenda:

1. Introductions & Meeting agenda

2. Generic Drug Web Conference – Feedback solicited **
 * who attended - any new questions?

Name: SPL R4 Training Generic Drug Products Session Date: **** Monday, July 21, 2008 **** Time: **** 11:00 a.m. **  ** 12:30 p.m. **** Location:Web Conference

3. Electronic Gateway - are you using it? How is it going?

4. Duns numbers - are you finding what you need?

5. Using DailyMed labeling vs. Drugs@FDA

6. Discuss face-to-face meeting with the FDA

7. Generic companies should have submitted all SPL by now ** Attendees: Please see separate Generic Team Roster The agenda was followed closely. Jeffery Karp (GeronMed) taking notes Summary: This meeting was mostly an information exchange session. There were several attendees. No new questions from the web conference. It was reported that some members of this subgroup are working on examples of submissions. Several team members and their companies are using the ESG for submissions. Q: Is this the same gateway used for other electronic submissions such as eCTD? A: Yes Q: Must we use the gateway for site registration and drug listing? A: Yes, this is the only way that you can site register or drug list. Q: How many accounts should a company have? A: If company has many submissions, it may be useful to have several accounts. Accounts are inexpensive (~$25 investment). It is useful to have several computers used for sending electronic submissions to the gateway to avoid bottlenecks. Q: We can't name more than one account with our company name. What should we do? A: A suggested solution is to name new accounts for the company followed by a username (For example, "superdrugcompany-jeffery") Tips and tricks  ·  The computer used for sending submissions should have the submissions files removed, especially large ones. Otherwise they will take up a large amount of disk space either slowing down or preventing new submissions to be performed on those computers. The process of submission creates copies of the submission as well as doing compression as part of the submission process. These files are not removed automatically after a submission. The cleanup after submission will not affect the submission that has been sent after the session is complete.  ·  If a company does not do many submissions, use one computer and at least 2 gateway accounts. This will allow a small set of people to be expert in how the ESG is used for submissions.  ·  Firewall issues - setting up an ESG account is not difficult but does require interaction between the labeling group and IT. There is testing that needs to be done especially if the company has a complex firewall. So do not expect this to be a five minute process but to take several weeks because of interactions between groups as well as the FDA. Several companies reported that different departments have the data needed for the new SPL R4 (Revision 4) requirements from those that were used in the SPL R3, used until now. New processes will need to be developed to incorporate these groups in to the SPL submission process. Q: How do you use the ESG for submissions? A:  ·  See the Electronic Submissions gateway at this URL - http://www.fda.gov/esg/  ·  At the SPL Process Team meeting (Aug 6), there was a presentation on the ESG  ·  The FDA has been requested to do a webinar on this subject. Advice Don't wait 'til last minute. Do not treat this period and submissions as a pilot period but as a transition not pilot > transition Question about 21 cfr 11 - validation for ESG submission process, asking what was being done at the various companies? General questions to group and discussion. How is it going? Several companies have a list but not all importers. This raised a great deal of discussion because the process for acquiring this information is complex. A second difficulty is that not all upstream manufacturers will have DUNs numbers. Several team members were very vocal about the need to communicate this to the FDA. Q: Can we get these numbers from the FDA? From a compiled list? From the wiki? From the Data Council page? A: Unresolved Q: Are all DUNS numbers for ingredients required? US (domestic) as well? A: Unresolved The process for submitting a 2657 form appears different from what is being requested in the new regulation. Q: Are inactive ingredients required? A: No. At some companies, there is a different group that performs registrations. A process needs to be established for coordination of registration - otherwise duplication is likely. Because of this it was suggested that FDA drug listing personnel were invited to participate in this group. Virginia Hogan is pursuing this. It was suggested that there was a need for examples and FAQ creation. A short discussion of the Wiki effort followed. To use the XForms tool  ·  see the website http://www.fda.gov/oc/datacouncil/SPL.html  ·  go to the bullet "Instructions for using Electronic Drug Establishment Registration and Drug Listing XForms v1.0"  ·  open the PDF and follow the instructions There were several calls by members of the group for more detailed guidance. The response was to see the four documents on the Data Council URL and see if most of the questions are answered there. The website URL is http://www.fda.gov/oc/datacouncil/SPL.html and the four documents are:  ·  [|Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Draft)]  ·  Structured Product Labeling Implementation Guide for FDA Drug Establishment Registration and Drug Listing v1.0 (updated July 10, 2008 ) [|PDF]  ·  Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v1.0 [|PDF]  ·  Instructions for using Electronic Drug Establishment Registration and Drug Listing XForms v1.0 [|PDF] Q: Are DUNS required for US agents? A: Yes Q: What are the differences between registering and listing? A: Discussion ensued. A comment was made regarding Dun & Bradstreet being a private company. Are there any restrictions made to the company with how it uses the information that must be provided by Drug companies? It was then noted that the DUNS is a government standard, used for customs and tracking and to help facilitate Homeland Security Agency. Q: For current RLD labeling -- what source should be used for the narrative? A: Use Drugs@FDA for approved labeling only. If no approved labeling, labeling reviewer may approve use of dailymed if it is the same as the approved labeling. Action: Please send comments on Draft Guidance to Virginia.Hogan@tevausa.com for collation and submission. Several meetings on the new draft guidance are scheduled: GPHA conference in Washington DC – October 28-30 - Drug listing and Site Registration meeting is on October 28, 2008 DIA meeting in fall – date to be determined. DIA webinar on Sept 9 - 11:00 am 2:00pm EDST Action Item: Dates and times for mtgs of generic group -- please send suggestions to Virginia.Hogan@tevausa.com. Proposed times are every other: Monday at 1:00, Thursday or Friday, times open. Action Item: Please send any questions not covered to Virginia Hogan Over 95% of proprietary drugs have been submitted. Only 70% of generics have SPL submitted. Reminder: Please get these completed before new regulations take effect.
 * 8. Any other business
 * 1. Introduction ** – Generics Sub team has been combined with GPhA SPL team. We will submit joint comments on the newly proposed guidance.
 * 2. Generic Drug Web Conference Attendees **
 * 3. ESG (Electronic Submissions Gateway) **
 * 4. DUNS Numbers **
 * 5. Using DailyMed labeling vs. Drugs@FDA **
 * 6. Discuss face-to-face meeting with the FDA **
 * 7. Generic companies should have submitted all SPL by now **