US panel votes 12 to 2 to recommend use of nasal vaccine, which has been reformulated to include a new influenza A strain.

Despite a CDC advisory committee recommendation that FluMist not be used in the forthcoming influenza season, FDA says the benefits of the nasal formulation outweigh any potential risks.

The apparently first-ever FDA press release for an advertising warning letter underscores importance of opioid issues – and the agency’s changing approach to media relations in general. FDA objects to Alkermes journal ad that excludes risk information about its opioid dependence treatment drug.