The Latest On Off-Label Responses

Law360, New York (January 5, 2012, 2:50 PM EST) -- On Dec. 27, 2011, the U.S. Food and Drug Administration released a draft guidance on how pharmaceutical and medical device manufacturers should respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use related to their FDA-approved or -cleared products.[1]

The draft guidance largely reaffirms the agency’s view that companies can respond to unsolicited requests for information about FDA-regulated products by providing truthful, nonmisleading scientific or medical information that is responsive to the specific request, even if such information relates to an...
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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.