(301) 594-6771

www.modafinil.com › fda is pursuant to; FDA Warning Letter - Modafinil Aug 12, 2020 · If you have any questions or comments, please contact James Rogers, Pharm.D., by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Pursuant to; Requested Action We request that you immediately cease the dissemination of sales aids, journal adverti*****ts, websites and all other promotional materials and activities for Provigil that contain the same or similar violations outlined in this letter. Your written response to the above request should be received no later than January 17, 2002. Your response should include a list of all promotional materials that are discontinued and the date that they were discontinued. If you have any questions or comments, please contact James Rogers, Pharm.D., by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm 17-1320, 5600 Fishers Lane, Rockville, MD 20857. We remind you that only written communications are considered official. In all future correspondence regarding this particular matter, please refer to MACMIS ID # 10183 in addition to the NDA number. Sincerely, James R. Rogers, Pharm.D. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications My comment deals with Thomas W. A***ms, R. Ph., MBA Director Division of Drug Marketing, Advertising, and Communications HTTPS://WWW.OUTSOURCING-PHARMA.COM/ARTICLE/2005/08/24/VIO**-SCANDAL-POINTS-TO-DEEPER-INDUSTRYISSUES HTTPS://WWW.OUTSOURCING-PHARMA.COM/ARTICLE/2005/11/30/MERCK-SLASHES-7-000-JOBS-AND-SHUTSMANUFACTURING- FACILITIES