Judge Gorsuch Could Be Pharma Ally In FDA Disputes
Supreme Court nominee's opposition to deference for administrative agencies could help biopharma industry in its battle over off-label communications if the issue ever goes before the court; he also supports securities litigation reform.
You may also be interested in...
Product Liability Returning To Supreme Court With Government, Former FDA Officials On Opposite Sides
Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.
Legal Briefs: Courts On Exclusivity; Namenda ‘Hard Switch’ Deemed Coercive; Acorda Fights Bass Patent Petition
FDA’s active moiety rationale for denying Vascepa five years exclusivity is rejected by district court; Actavis strategy to protect Namenda franchise meets another hurdle; Acorda challenges ‘improper purpose’ of Bass IPR petition.