Making individual patient-level data available for other research presents companies with challenges, but researchers and companies can take steps to minimize the risks.
Originally published in Drug and Medical Device,...more
"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more
4/13/2018
/ Biopharmaceutical ,
Clinical Trials ,
Expanded Access Programs (EAPs) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Preemption ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Oversight ,
Right to Try ,
Terminal Illness Treatments
Two recent cases in state appellate court show the risks of sharing privileged communications with public relations consultants. But they also provide practical guidance on how to protect the confidentiality of...more