Industry Communications With Payors: US FDA Okays Info On Investigational Drugs
Executive Summary
Draft guidance provides clarity on what health care economic information firms can provide to payors, formulary committees and similar entities.
You may also be interested in...
‘We Don’t Hold Regulatory Actions For Press’ – Inside FDA’s Communications Difficulties And Misinformation Fights
Internal US FDA emails illustrate the difficulties coordinating regulatory decisions and communications about them as the agency considers growing its allies in the war against misinformation.
Preapproval Information Exchange Between Sponsors, Insurers Clarified In House User Fee Bill
By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.
FDA Creates Division To Support First Amendment Policy Development, Oversee Advertising Research
Multiple unfavorable court decisions have forced the agency to adjust its advertising enforcement strategies.