Generic Industry Wants US FDA To Consider Allowing Foreign Reference Products For ANDAs
Executive Summary
If agency adopts policy, it might obviate the need for the CREATES Act. Biosimilars already enjoy a degree flexibility of on the source of reference material that generic sponsors want extended to the less complicated small molecule drugs.
You may also be interested in...
BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?
Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.
Gottlieb Tells Brand Firms To Sell Samples For Generics – Or Face The Consequences
The idea could help quiet growing criticism over system gaming and high drug prices.
Pay-for-Delay Bill Aimed At Blocking Brand/Generic Deals Gets Lower-Than-Expected Savings Estimate
CREATES Act and 180-day exclusivity reforms also in legislation headed to US House floor, even as generic industry remains opposed to two of the three main provisions. The Rx pricing language is bundled with Obamacare language designed to force a tough vote by Republicans.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: