Manufacturer Communications With Payers Easier Under US FDA Guidance, But Challenges Remain
Executive Summary
Process for sharing health care economic and other information has been simplified for manufacturers, and payers are seeing more economic modeling data earlier as a result. However, there is still uncertainty as to the scope of who may communicate the information, and to whom, under the agency’s 2018 final guidance, experts said.
You may also be interested in...
US FDA Extends Payor Communications Safe Harbor To Off-Label Uses
Final guidance on drug manufacturer communications with payors adopts industry call to include exchanges about unapproved uses; they will not be considered evidence of intended use.
Industry Communications With Payors: US FDA Okays Info On Investigational Drugs
Draft guidance provides clarity on what health care economic information firms can provide to payors, formulary committees and similar entities.
Postmarketing Safety Gets Closer Focus In Latest US FDA Drugs Center Reorganization
Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: