Article: FDA turns down OTC Plan B; outlines necessary information for approval.

Article: Morning-after pill gets nod from FDA advisory ...
Chain Drug Review;  January 5, 2004 ;     700+ words ... ... product in a few weeks. While FDA Commissioner Mark McClellan ... month's recommendation by the FDA's nonprescription drugs and ... and chief operating officer of Barr Research, the product development wing ... If ultimately approved by the FDA, O-T-C access to Plan B ...

Article: Barr Research, Bala Cynwyd, PA, Dec. 29 ...
Warning Letter Bulletin;  January 1, 2005 ;     452 words ...In a review of Barr's DTC television advertisement for Seasonale (levonorgestrel/ethinyl estra-diol) Tablets, DDMAC concluded the ad was misleading because it failed to reveal material facts about Seasonale and minimized the risks associated with the product. For example, the Seasonale TV ad

Article: FDA turns down OTC Plan B; outlines necessary information ...
Medical Letter on the CDC & FDA;  May 30, 2004 ;     700+ words ... ... letter to the sponsor, Barr Research, the FDA outlined the additional ... old, the agency said. FDA's letter to Barr Research noted that the application ... the sponsor of Plan B, Barr Research, has allowed FDA to comment in general ...

Article: OC label changes also at issue: FDA draws fire on failed ...
OB GYN News;  June 1, 2004 ;     700+ words ... ... teleconference sponsored by the FDA that he was not in agreement with his review staff or the FDA advisory committee with regard ... approvable" letter sent to Barr Research, the maker of Plan B. marks ... according to information on the FDA Web site. Dr. Galson also ...

Article: FDA delays guidance on how to market lower-cost copies of ...
Validation Times;  October 1, 2004 ;     700+ words ... ... of Biotechnology Products, FDA Center for Drugs, said in an ... legislation is passed giving FDA the authority to regulate follow ... D., president and CEO of Barr Research, in Congressional testimony ... and fall, stakeholders and FDA agreed to consider adopting ...

Article: FDA issues not approvable letter to Barr Labs; Outlines ...
M2 Presswire;  May 7, 2004 ;     682 words ... ... Steven Galson, Acting Director of FDA's Center for Drug Evaluation ... Although U.S. law prohibits FDA from discussing pending applications ... instance the sponsor of Plan B, Barr Research, has allowed FDA to comment in general terms on ...

Article: Ob/gyn group issues statement on FDA's non-approval of OTC ...
Medical Letter on the CDC & FDA;  June 6, 2004 ;     700+ words ... ... over-the-counter status for Barr Research's emergency contraceptive ... and Drug Administration's (FDA) action is a tragedy for American ... evidence-based agency like the FDA. This decision to ignore an ... today. In December 2003, two FDA expert advisory panels overwhelmingly ...