Some US Generics May Get To Skip Fed Studies
Requirement May Be Removed If US FDA Research Pans Out
Executive Summary
Office of Generic Drugs official says the FDA may be able to harmonize its requirements with regulators who do not have a blanket mandate.
You may also be interested in...
Generic Industry Market Forces May Impact GDUFA III Talks
AAM's Chip Davis said a user fee cut is not in order, but industry consolidation and product launch problems may mean it cannot accept another large increase.
At US Generic Association Annual Meeting, Worries About Sustainability
ANDA sponsors fret price erosion – and potential changes to 180-day exclusivity.
FDA's Off-Patent, Off-Exclusivity List Draws Few Takers Early On
US agency has received 'very few' inquiries about the drugs on the list since its release.