Why Bank Regulation Failed: Designing a Bank Regulatory Strategy for the 1990s
News Unfiltered (Free subscription) | 11/19/2009
... both consumers and merchants," said Shawn Miles, MasterCard head of global public policy and regulatory strategy. Full release.
Medical News Today (Free subscription) | 11/10/2009
... is within 300 days. "We are pleased to have completed another key milestone in our North American regulatory strategy for Ceplene®," stated Jack Talley, President and Chief Executive Officer of EpiCept. "As the next step in this process, we are focused on the filing of a New Drug Application for Ceplene® with the U.S. Food and Drug Administration for AML remission maintenance. As...
Fiercebiotech (Free subscription) | 11/06/2009
... development and commercialization of blinatumomab, Micromet can develop an integrated clinical and regulatory strategy across multiple commercial territories, starting with the first pivotal study that we expect to initiate in 2010." - read Micromet's release Related Articles: Micromet inks $475M antibody deal with Sanofi Micromet raising up to $80M to fund acquisitions, research...
Market Wire (Free subscription) | 11/04/2009
... Learned and Where are We Going? A CMO's Perspective John McGrath, Lonza Biologics -- Global Regulatory Strategies for Validation and Transfer of Biotech Processes and Products Robert L. Garnick, Ph.D., Lone Mountain Biotechnology and Medical Devices, Inc. -- The Critical Elements of a Successful Regulatory Filing for Outsourcing Biopharmaceutical Manufacturing Terry...
PR News Wire (Free subscription) | 10/30/2009
... surgery and abdominal surgery. The FDA provided AcelRx with guidance on Phase 3 study design, regulatory strategy, and NDA requirements. Commenting on the meeting, Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer stated, "We are glad to have FDA input on the NDA requirements for this novel approach to post-operative pain management. Given this guidance, our path to market...
The Earth Times Online Newspaper (Free subscription) | 10/30/2009
... surgery and abdominal surgery. The FDA provided AcelRx with guidance on Phase 3 study design, regulatory strategy, and NDA requirements. Commenting on the meeting, Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer stated, "We are glad to have FDA input on the NDA requirements for this novel approach to post-operative pain management. Given this guidance, our path to market is now...
