What’s A "Complete" Application? Clarity From FDA Could Speed Review Times
A clarification of what constitutes a complete application likely will be included in a package of review process changes expected in the Prescription Drug User Fee Act reauthorization.
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ANDA Backlog Withdrawals May Stimulate Secondary Market By Foreign Firms
Applications removed from the backlog to avoid GDUFA charge may generate interest from sponsors looking to gain quicker entry into the U.S. market, but work likely would still be required to gain approval.
Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model
NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.
PDUFA V: FDA Application Completeness Crackdown Continues
FDA remains firm in its push for application completeness in PDUFA V, despite its willingness to add two new review cycle meetings with sponsors.