Product Safety Update Report Burden Of Analysis Is On Sponsors, FDA Says
Executive Summary
Sponsors would bear responsibility for analyzing safety data under FDA's plans to implement product safety update report requirements established by the International Conference on Harmonization.
You may also be interested in...
ICH To Address Postmarketing Issues As Possible Topic At May Meeting
Postmarketing issues surrounding drug products will be taken up as a new topic for consideration at the May meeting of the International Conference on Harmonization Steering Committee in Tokyo.
Off Label Drug Use Data To Be Required In Periodic Safety Updates - FDA
Pharmaceutical companies will be asked to provide postmarketing drug usage information in their periodic safety update reports, including use in off label indications, under a proposed FDA rule due out later this year.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011