Pharma Should Enlist Patients, Physicians To Fight Off-Label Litigation
Drug makers should partner with patient advocacy groups and physicians to fight a growing pattern of litigation related to the dissemination of off-label drug information, Sidley Austin Brown & Wood Partner Paul Kalb said during a Drug Information Association workshop Feb. 22 in New York
You may also be interested in...
Responsibility for coordination of federal off-label promotion investigations should be transferred to the Department of Justice Criminal Division to help ensure appropriate protection of First Amendment rights, the Washington Legal Foundation said in a recent petition to DoJ
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
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials