Generics+--+9-8-08+minutes

SPL Process Team - Generic Drugs Subgroup Meeting September 8, 2008, 1pm EDST Meeting Minutes

Agenda for SPL Generic Sub Team Meeting September 8, 2008 1. Meeting minutes – any comments? 2. Wiki – has anyone logged in? 3. Comments – due to the FDA tomorrow. Will submit via e-mail. 4. DIA Webinar tomorrow – 76 signups so far. 5. GPhA F2F – SPL R4 – October 28 in Washington, DC. Virginia Hogan/Teva will attend representing Generic Sub Team. 6. DIA F2F – SPL R4 – October 29 & 30 in Philadelphia. Jeffery Karp/RA-IT Associates will attend representing Generic Sub Team. 7. Waivers for SPL R4 – will be difficult to obtain. 8. Look at whole process for your company.


 * 1. Meeting minutes – any comments?**

Minutes accepted without comment


 * 2. Wiki – has anyone logged in?**

Several people have.

Some notes on what is available on the wiki. Submissions flow - "Submissions Flow Chart for R3 and R4" Docket comments - "Important Documents" DUNS Number - "DUNS Number FAQ" There is a possibility of tying the Wiki to the HL7-SPL information.


 * 3. Comments – due to the FDA tomorrow. Will submit via e-mail.**

Waiver Comment about one waiver – from the federal register – 1 registration per company per year - one waiver annually Lonnie responded about low number of waivers expected to be necessary

Costs Comment about costs Per label costs high Process change cost significant

DUNS DUNS cost significant – credit report plus duns; can’t get it without doing it this way if the company doesn’t know the DUNS number – Lonnie says will ask from D&B at the seminar

Questions about DUNS numbers What’s the minimum info to give D&B so the registration number could be gotten without this major expense? Is that a way that would work to reduce the workload on both sides as well as the cost? Craig T to follow-up at Webinar on September 9 Question – find vendors DUNS number - finding vendors on our own is less expensive but requires time (extensive time – both calendar and effort) Is the NDC OK rather than DUNS? FDA response: NDC lets FDA know what establishment is involved – that is acceptable (for right now) FDA says – Information from Ryan Paul at D&B – about $4 per DUNS if you have account. Is there an initial $5000 membership fee required? This will be checked

Layout Order of comments – The comments will be put in a priority order.

. This is the September 8 Webinar. Several members are attending.
 * 4. DIA Webinar tomorrow – 76 signups so far**


 * 5. GPhA F2F – SPL R4 – October 28 in Washington, DC.**

Virginia Hogan/Teva will attend representing Generic Sub Team.

DIA F2F – SPL R4 – October 29 & 30 in Philadelphia.**
 * 6.

Jeffery Karp/RA-IT Associates will attend representing Generic Sub Team.


 * 7. Waivers for SPL R4 – will be difficult to obtain.**

Discussion above


 * 8. Look at whole process for your company.**

Different departments being merged to make this process into one group. Need feedback from other companies to see how this is affecting you.


 * 9. Other/New**

Meeting participation is strongly encouraged. One method suggested is contacting group members regarding issues for future meeting agenda. Another is a survey/questionnaire to establish the needs of the group.

Slides from webinar will be sent out with Meeting Minutes. It was confirmed by D&B that if just a DUNs number is requested the cost should be $3.55. No membership fee is required. Our comments were sent to the FDA via GPhA under their letterhead.
 * 10. New developments after SPL Generic Sub Team Meeting:**


 * 10. Meeting attendee list below.**

If you attended and are not on the list, please let me know.


 * 11. The next Generic Sub Team meeting is on Monday, September 22**

Please send me any agenda items you wish to be discussed. Call in information: Toll Free Dial In Number: (866) 618-6746 Int'l Access/Caller Paid Dial In Number: (201) 527-2133 ACCESS CODE: 8957842 Generic Sub Team – Attendees 9/8/08 Name ** || ** Company ** || Brunone, Theresa || Glaxo Smith Kline || Cobham, Michele || Par Pharmaceutical || Desai, Mona || Par Pharmaceuticals || Feliciano, Iris || Sun Pharmaceutical Industries, Inc || Frahn, Jane + 4 team members || Teva Pharmaceuticals || Halleran, Sue || West-ward Pharmaceutical Corp.  || Harvey, Mary || Qualitest Pharmaceuticals || Hogan, Virginia Generic Sub Team Leader || Teva Pharmaceuticals || Karp, Jeffery Generics Team Minutes || RA-IT Associates || Lempka, Gayle || Watson || Nguyen, Wafa || Qualitest Pharmaceuticals || Peritore, Sal || Barr Laboratories, Inc || Richesson, Cathleen || Ben Venue Laboratories || Saner, Gary - John Lorenc attended for Gary || Reed Technology || Santoro, Amanda || Hospira || Shieh, Betty || Teva Pharmaceuticals || Smith, Lonnie || FDA || Tenaglia, Paul || Apotex, Inc.  || Thibodeau, Wendy || Sandoz || Todd, Susan || West-ward Pharmaceutical Corp.  || Troutman, Craig || Intagras || Vasquez, Karen || Roxane Laboratories, Inc || Cheng, Evelyn || Teva Global Respiratory Research, LLC ||