US FDA Drug Review Goals Should Be Faster In PDUFA VII, Industry Negotiators Propose
Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.
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Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
Sponsors will receive additional agency interactions through the formal meeting process, as well as an option to ask clarifying questions later.
A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.