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- Generic Drug Strategic Alliances: Competitive Opportunities And Antitrust Risks
- Generic drug firms face a myriad of competitive challenges. There are scores of strong competitors and an absence of significant entry barriers. Generic firms typically offer a significant number of products but lack the financial wherewithal, marketing depth, and financial resources of branded pharmaceutical firms. To better compete in this...
- White papers 2003-04-01
Additional Resources
- FDLI 50th Annual Meeting Heralds New ERA in Healthcare Innovations, FDA Regulations
- To: MEDICAL EDITORSTo: MEDICAL EDITORS
- Research articles 2007-04-30
- FDA concerned at biologics claims
- THE FDA biologics center's biggest concerns when reviewing sponsors' promotional materials is "unsubstantiated comparative safety claims and minimization of risks," Advertising and Promotional Labeling Branch APLB chief Glenn Byrd told a Food and Drug Law Institute FDLI conference in Washington, DC.
- Research articles 2003-11-01
- EPA Launches Major Nanotechnology Monitoring Project; Top Government Officials to Speak at FDLI Conference
- To: TECHNOLOGY EDITORS To: TECHNOLOGY EDITORS
- Research articles 2008-01-29
- Abigail Alliance Will Appeal D.C. Circuit Court Decision
- To: POLITICAL EDITORSContact: Michael Levin-Epstein, Editor-in-Chief of Food and Drug Law Institute, +1-202- 222-0897, mdl@fdli.org WASHINGTON, Aug. 22 /PRNewswire-USNewswire/ -- The battle over whether terminally ill patients have a constitutional right to access experimental drugs is far from over, says Scott Ballenger, the attorney representing Abigail Alliance in its lawsuit...
- Research articles 2007-08-22
- FDA-SEC partnership raises questions about disclosure of development and trial reports
- WASHINGTON -- FDA's efforts to have drug and biologics makers disclose their "development reports" as part of the agency's drug quality initiative could present some exposure industry had not realized due to the agency's new working agreement with the Securities and Exchange Commission SEC. Addressing the Food and Drug...
- Research articles 2004-04-01
- Effective quality system to ensure regulatory compliance essential in DOJ's eyes, says Hospira exec
- WASHINGTON -- When designing a quality assurance system, keep in mind that if criminal charges are ever lodged against a firm, the U.S. Department of justice will take into consideration "the existence and adequacy of a corporation's compliance program," according to Hospira's VP of ethics and compliance here April 7....
- Research articles 2006-04-01
- Itron, Inc. Q1 2009 Earnings Call Transcript
- Question-and-Answer SessionOperator Thank you. Operator instructions And your first question comes from Steve Sanders with Stephens Inc. Steve Sanders – Stephens Inc. Good afternoon, everyone. Deloris Duquette Hi, Steve. Malcolm Unsworth Hi, Steve. Steve Sanders – Stephens Inc. I guess first on the guidance, it looks like Actaris in...
- Earnings calls 2009-04-29
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