FDA draft guidance outlines what drugmakers can and can't tell insurers about unapproved products, with real-world evidence examples also released.
June 3, 2026 12:55 PM EDT
FDA+
Explaining unapproved drugs to payors: FDA offers pharma new guidance to avoid pitfalls
Zachary Brennan
Biopharma companies preparing to launch the next practice-changing blockbusters want payors to know what’s coming before they ultimately land an FDA approval. The trick is …
FDA issues untitled letter after finding ‘eye-catching graphics’ in promotional emails
Fueling Pharma's AI Revolution with the Right Content, Governance and Licensing Strategy
Legend Biotech emerged as a rare market winner
ADHD drug delivery specialist Cingulate hit with manufacturing-related FDA rejection
The FDA's new path, the status of animal testing, and other biotech news from The Readout
The FDA is looking to get thrifty with its approved drugs. | The framework would leverage existing safety data on approved drugs…
The FDA has hit QOL Medical with an untitled letter over emails about Sucraid, accusing the company of creating a misleading…
New CBER draft guidance further explains to cell and gene therapy developers the types of prior knowledge companies can leverage…
The FDA has issued draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer…
The rise of direct-to-consumer channels, driven largely by consumer willingness to pay for GLP-1s for weight loss without using…
