Complex Generics: Pre-Competitive Research Collaborations To Get US FDA Funding Boost
Executive Summary
Center for Research on Complex Generics will be similar to the Critical Path Institute; training sessions for industry could begin in January.
You may also be interested in...
FDA And Industry Set Out GDUFA III Priorities
Both first-cycle approvals and priority assessment improvements have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.
GDUFA III: First-Cycle Approval, Priority Assessment Improvements Are Early Priorities
Both issues have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.
Generic Drug Bioequivalence Study Interruptions Not Just A Coronavirus Problem
US FDA should create a policy to help save troubled studies, because failure can kill generic development programs, Lachman Consultants’ Michelle Ryder suggests.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: