generics+--+8-25-08+minutes

 OK to send out names, business and e-mails with minutes? Will not send out titles or phone numbers. //Upcoming DIA Meetings: // September 9, 2008  – SPL webinar End of October – 1 ½ day face-to-face SPL meeting – Oct 29 & 30 in Philadelphia //Upcoming GpHA Meeting: // October 28-30, 2008  - Fall Technical Workshop - 1 day SPL face-to-face meeting on October 28th in DC VH is working with Michael Fahmy to establish a Q&A format for Wiki. A few questions I received from team members: Q1. I had thought that I heard FDA saying, more than once, that they want to know who the supplier of the API(s) in a product are. But when I look at the Xform, there is no place where you indicate the supplier of the API. Q2. I have contacted Dunn and Bradstreet regarding obtaining the Dunn's # for our vendors. Is there a way to obtain this information on line or must you request a full credit report on each of your vendors which would then provide you with the Dunn's #'s. Q3. On instructions for using Electronic Drug Establishment Registration and Drug Listing, XForms v1.0: 4.5 Establishment The establishments are the entities involved in the manufacturing or processing the drug product. Enter one or more establishments. This information includes the name, DUNS Number and types of operations. <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">How many levels do we need to supply? <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">The agenda was followed closely. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">Jeffery Karp (GeronMed) taking notes <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">There were no questions or comments on the minutes. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">There were no objections to publishing the group member list. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">A list of opportunities was included in the agenda. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">If the difficult choice arises of which meeting to attend, the following pieces of information may help: <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">The DIA meeting is more general and will draw more vendors. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">The GpHA meeting will be more specific in addressing the needs of the Generic Pharma companies. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">A great deal of discussion regarding the use of XForms for establishment registration. One company with many products and many establishments noted several objections with using the free tool. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">The same sponsor company found it difficult to get other vendor support to do the SPL R4 work as well. They are currently in the process of interviewing vendors to find a solution. This company is very concerned that they may not find a solution in a sufficiently timely fashion and are in the process of requesting a time extension for implementation of the rule. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">It was also noted that XForms is not validated and would be difficult to validate. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">There is no need to get a DUNS number if the establishment is already registered. The NDC for that may be used. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">Jeffery Karp (GeronMed, RA-IT Assoc) gave a brief introduction to the Wiki that is in-process. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">A wiki should always be in-process. The word means “quick” in Hawaiian. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> A **wiki** is computer server software that allows users to easily create, edit and [|link] web pages. Wikis are often used to create [|collaborative] [|websites], power community websites, and are increasingly being installed by businesses to provide affordable and effective [|Intranets] or for use in [|Knowledge Management]. [|Ward Cunningham], developer of the first wiki, [|WikiWikiWeb] , originally described it as "the simplest online database that could possibly work".[|[1]] One of the best-known wikis is [|Wikipedia] .[|[2]] <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">Quote from Answers.com <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 16pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">Please go there and try it out. We appreciate any feedback. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">There are sections in the wiki for the Generics subgroup as well as the other subgroups. There are also sections for processes and FAQs (Frequently Asked Questions). Any page may have discussion items added. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">Currently, leaders of each group and the wikimaster can make changes and add additional pages. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">FDA documents for comments have been placed on the site. The document, “ **__<span style="FONT-FAMILY: 'Arial','sans-serif'">Draft Guidance - Providing Regulatory Submissions in Electronic Format of Drug Establishment Registration and Drug Listing” __**<span style="FONT-WEIGHT: normal; FONT-FAMILY: 'Arial','sans-serif'; mso-bidi-font-weight: bold"> ** is available at  ****<span style="FONT-WEIGHT: normal; FONT-FAMILY: 'Arial','sans-serif'; mso-bidi-font-weight: bold">: ** <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">http://spl-work-group.wikispaces.com/Draft+Guidance+-+Electronic+Submission+of+Establishment+Registration+and+Drug+Listing <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">Comments may be left by using the discussion tab. The same is true for comments on any of the wiki pages. Comments for this document are needed quickly. <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'"> Following up with you and the information I shared at the Teleconference yesterday. In regard to obtaining the DUN's registration No. As I stated this has been a very time consuming task. I pulled a complete vendor list from our system, and started working off that. Our Accounting Department was kind enough to advise me what vendors we no longer use. This whole process was started on August 8, 2008, and at this time I have contacted all our vendors, and have received approximately 3/4 of the DUN's registration No. from our vendors. All have been very cooperative, and those that have had additional questions they have e-mailed or called and after explaining the whole situation, have been very understanding. I am right now doing all my follow-ups to those who have not yet responded. I have contacted ALL vendors, - API's and excipients as at the time the decision was not firm whether we were just to use the API's.
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">SPL Process Team - Generic Drugs Subgroup Meeting **
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">Aug 25 2008 ****<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">, 1pm EDST **
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">Meeting Minutes **
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">Proposed agenda: **
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">1. Meeting minutes – Any Questions? **
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">2. Training Opportunities: **
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">3. Further discussion of drug listing **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">, read X-form prior to meeting to be prepared. We will put together a list of scenarios/situations that you have questions about and send them to the FDA.
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">4. What is Wiki anyway? **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'"> - Jeffery Karp brief discussion.
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">5. Q & A: **
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">6. Need to get comments on the Guidance to FDA by Monday Sept 8th. **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'"> Need comments to me by the end of this week.
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">7. Next meeting is September 8 at 1:00 pm. **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">
 * <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">Summary: **
 * <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">1. Meeting Minutes **
 * <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">2. Training **
 * <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">3. XForms **
 * 1) <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">There is no support from the FDA or GlobalSubmit (the vendor) for XForms beyond the instructions.
 * 2) <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">The FDA says and the company concurs that the software was setup as a test and not for a full production environment for a company with many products.
 * <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">4. Wiki **
 * <span style="FONT-SIZE: 16pt; FONT-FAMILY: 'Times New Roman','serif'">The wiki for the process team and the subgroups is **
 * <span style="FONT-SIZE: 16pt; FONT-FAMILY: 'Times New Roman','serif'">http://spl-work-group.wikispaces.com **
 * <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">5. Q&A **
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">Q1 **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">. <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">I had thought that I heard FDA saying, more than once, that they want to know who the supplier of the API(s) in a product are. But when I look at the Xform, there is no place where you indicate the supplier of the API.
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">A1. **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">You put it in the establishment field. You don’t have to note that it is an API. (You can only list a product or an establishment in this field.)
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">Q2 **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">. I have contacted Dunn and Bradstreet regarding obtaining the Dunn's # for our vendors. Is there a way to obtain this information on line or must you request a full credit report on each of your vendors which would then provide you with the Dunn's #'s?
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">A2 **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">. Several parts of the answer were given at the meeting, including discussion of how to register with Dun and Bradstreet, and basic costs. A response from Sue Halleran who added a great deal to the discussion came in yesterday. This more complete discussion appears below:

The actual cost was 3500.00 for the first 50 reports, after speaking with Tom at DUNN and BRADSTREET he advised he would give us a 10% discount for each 25 reports after that.

Should you need anything further or I can help anyone regarding this please feel free to contact me and I will be glad to help anyone with this.

Thank you

Sue Halleran

<span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: 'Courier New'">Virginia <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: 'Courier New'"> followed up with 2 questions: // DUN"s Registration No. - I would like to request your DUN's registration No. (D&B #) we now must include this on our correspondence to the Food and Drug Administration regarding drug establishment listing and registrations. - We currently are receiving **** from you. // // Should you have any further questions or concerns regarding this please feel free to contact me. // 4.5 //Establishment//  The establishments are the entities involved in the manufacturing or processing the drug product. Enter one or more establishments. This information includes the name, DUNS Number and types of operations. <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">How many levels do we need to supply? <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">The wiki may be used as well. Gary Saner has volunteered to help collate and assemble the comments.
 * <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">Q2.1 **<span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: 'Courier New'"> <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: 'Courier New'">Do you have a form letter that you send to your vendors that you would be willing to share?
 * <span style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman','serif'">A2.1 ** My e-mail basically stated:
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">Q2.2 **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: 'Courier New'">It would also help is if we know how many products that you were working from, how many vendors you contacted (I think you said 250?) and how many hours you have spent on this to get 75% finished. (Also, the last 25% may be the hardest since you have not heard from them yet.)
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">A2.2 ** Once I get the complete list done I will be able to give you an accurate number as to how many companies I contacted and how many products that involved <span style="FONT-SIZE: 13pt; COLOR: blue; LINE-HEIGHT: 115%; FONT-FAMILY: 'Arial','sans-serif'">. <span style="FONT-SIZE: 10pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Arial','sans-serif'">
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">Q3 **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">. On instructions for using Electronic Drug Establishment Registration and Drug Listing, XForms v1.0:
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">A3. **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">You need to list anyone that you used in the process to manufacture the product. This discussion was cut short as we had gone over the hour allocated for this meeting. We will discuss this further at the next meeting.
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">6. **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial"> **Need to get comments on the Guidance to FDA by Monday Sept 8th. Need comments to Virginia by the end of this week. **
 * <span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">7. Next ****<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'">meeting is September 8 at 1:00 pm. Please send agenda items to Virginia Hogan. **<span style="FONT-SIZE: 12pt; LINE-HEIGHT: 115%; FONT-FAMILY: 'Times New Roman','serif'; mso-bidi-font-family: Arial">