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GDUFA: FDA Sees High Fee Collection Rate After First Six Months

Executive Summary

About 24% of facility fees and 20% of all fees are outstanding, but industry officials also want to measure success through FDA hiring and communication.

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FDA Generics Office Gets Third Director In Three Workdays; Uhl Brings Policy, Pharmacology Experience

A long-time FDA veteran who remains largely unknown to the generics industry, Kathleen Uhl replaces CDER Director Janet Woodcock as acting director of the Office of Generic Drugs effective March 19 following Gregory Geba’s March 15 departure from the generic office’s top post.

FDA Generics Director’s Departure Shows Why Chemistry Matters

Another outside candidate is expected to eventually take over for the departing director Gregory Geba, and while the Office of Generic Drugs can run smoothly without a permanent leader for now, it cannot do so forever.

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FDA still has backlog fees in arrears more than two months past the payment deadline, but cannot forcibly withdraw the applications; facility listings also change consistently because industry can update them as needed.

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