Mandatory Efficacy Trials: US FDA Affirms Broad Scope Of New Post-Market Authority
Executive Summary
Updated guidance on its authority to mandate postmarketing studies affirms that a new power to impose requirements to look for diminished efficacy reaches beyond the opioid drug class.
You may also be interested in...
US FDA's Postmarket Study Requirements: Industry Wants Standardization, Expert Input
PhRMA, BIO and Pfizer call for predictable process for setting postmarket commitments and requirements, periodic reevaluation of their necessity and feasibility, and FDA acceptance of novel trial designs.
Opioid Approvals: Congress Wants US FDA Guidance On Abuse Potential
Instead of creating new mandate, legislation tells FDA to outline how risk-benefit decisions could be influenced by a product's abuse potential under existing approval authority; final opioids package expected to reach the White House soon.
A Final Push For US Hepatitis C Eradication Plan In 2024
The Biden Administration is hoping that it can attach funding for a national hepatitis C ‘subscription’ program into the delayed fiscal 2024 appropriations bills.