Thank you for attending FDLI's 54th Annual Conference
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Photos by Shira Yudkoff
News from the 2011 Annual Conference
A Long Overdue Reform at FDA to Spur Innovationby GoozNews
Panelists Discuss BPCIA Implementation, Combo Product Opportunities, Challenges
by John T. Aquin, Life Sciences Law & Industry, BNA, INC
Reproduced with permission from Life Sciences Law & Industry Report,
5 LSLR 353 (Apr. 8, 2011). Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033)
Actions on HIV Home Test Kits, Other Issues Discussed by
CBER Compliance Director
by John T. Aquino, Life Sciences Law & Industry, BNA, INC
Reproduced with permission from Life Sciences Law & Industry Report,
5 LSLR 353 (Apr. 8, 2011). Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033)
CDER's Priorities Include User Fees, Biosmiliars, REMS,
Woodcock Says
by Bronwyn Mixter, Life Sciences Law & Industry, BNA, INC
Reproduced with permission from Life Sciences Law & Industry Report,
5 LSLR 353 (Apr. 8, 2011). Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033)
Agency Officials Say Priorities Include Promoting Innovation,
Science, Enforcement
by Nathaniel Weixe, Life Sciences Law & Industry, BNA, INC
Reproduced with permission from Life Sciences Law & Industry Report,
5 LSLR 353 (Apr. 8, 2011). Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033)
Attorneys Discuss Cases of Interest to Drug, Device Firms, Predict Trends in Litigation
by Dana A. Elfin, Life Sciences Law & Industry, BNA, INC
Reproduced with permission from Life Sciences Law & Industry Report,
9 PLIR 471(Apr. 15, 2011). Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033)
Socially Adept: Pharma Companies Must Proactively Gauge Risk Tolerance For Online Promotions, Experts Advise
by Sue Sutter, "The Pink Sheet" Reproduced with permission
from Elsevier Business Intelligence
Disclosing Drug Development Failures Would Aid Regulatory Science, FDA's Hamburg Says
by Sue Sutter, "The Pink Sheet" Reproduced with permission
from Elsevier Business Intelligence
FDA Oversight Of Medical Products Remains A "High-Risk" Concern For GAO
by Jessica Bylander, "The Gray Sheet" Reproduced with permission
from Elsevier Business Intelligence
CBER Director Sees Behind-The-Counter Switches As Best Bet
by Malcolm Spicer, "The Tan Sheet" Reproduced with permission
from Elsevier Business Intelligence
Blog Posts
FDA and User Fees: Time to Give 100%?
by Michael McCaughan, The RPM Report,
Elsevier Business Intelligence, posted 4/11/11
FDA data on failed medical devices, drugs may be released
by Merrill Goozner, posted 4/06/11
Mingling with our FDA Friends
by Steve McConnell, Drug and Device Law, posted 4/11/11
FDLI Tobacco Products Panels Discuss Challenges and New Opportunities
by Brian J. Malkin, posted 4/14/11