Although the US FDA can send letters to brand companies on behalf of generic sponsors seeking samples of drugs covered by risk evaluation and mitigation strategies (REMS), innovators are cautioning there are other components to account for that make providing samples difficult.
John Murphy, deputy general counsel for the Biotechnology Innovation Organization (BIO) contends that the organization's smaller members have raised concerns about their supply, in that there are instances where biotech products are "not produced in a
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?