FDA Needs To Revamp Benefit-Risk Analysis, Drugmakers Say

Law360, New York (May 15, 2013, 7:56 PM EDT) -- The U.S. Food and Drug Administration’s new process for analyzing a drug’s benefits and risks needs to be drastically expanded, patient groups and drug companies have argued, saying if the agency did a benefit-risk calculation at every stage of the drug review process rather than as a final step, it could get more drugs to market, and faster.

In March, the FDA released a draft plan for implementing a new benefit-risk assessment and incorporating more patient perspective in the drug review process, and invited stakeholder comments...
To view the full article, register now.

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.