FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CDER’s Regulatory Modernization Will Peak in 2019, Woodcock Says

Feb. 15, 2019

CDER’s efforts to modernize its new drug regulatory program will reach “a crescendo” in 2019, according to CDER Director Janet Woodcock.

The center will roll out its new review process for NDAs, BLAs and accompanying documentation this year, leading to a shift towards team-based reviews across different scientific disciplines, she said in an agency podcast. She called the new review process a “very, very exciting change for how we do things.”

The center also expects to have its proposed reorganization approved by HHS towards the end of FY 2019, though the director noted this isn’t guaranteed. The proposal includes an overhaul of four CDER offices — the Office of New Drugs, the Office of Compliance, the Office of Executive Programs and the Office of Communications — intended to enhance the center’s ability to respond to new priorities.

CDER is also working on putting together a regulatory framework for 503A compounding and outsourcing facilities, Woodcock noted.

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