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July 02, 2011
Follow-on versions of complex biologics require extensive expertise in development and regulatory procedures.
June 02, 2011
Industry struggles to curb drug abuse, diversion, and disruptions in supply.
May 02, 2011
FDA, NIH and industry seek new strategies to spur drug development and promote access to therapies.
April 02, 2011
Courts and Congress seek to reshape policies and programs.
March 02, 2011
As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.
February 02, 2011
Food-safety, transparency, and counterfeit-drug growth will tax agency resources.
January 02, 2011
Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.
November 02, 2010
A new center may provide evidence for improving care, but could discourage coverage of treatments.
October 02, 2010
President Obama and HHS eye innovation and countermeasures to protect public health.
September 02, 2010
Weighing the pros and cons of REMS for bringing risky products to market.