Woodcock Wants Rapid Regulatory Policy Development
CDER Director says US FDA needs to develop statistical and other guidances faster to keep up with the pace of science and drug development.
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Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.
Label Expansion: Could Clinical Experience Data Find Supplement Work-Around?
Friends of Cancer Research seeks way of allowing high-quality efficacy data into label when supplemental NDA is not feasible.
Gottlieb Promotes 'Bottom-Up' Review To Increase FDA Efficiency, Consistency
US FDA commissioner nominee suggests breakthrough concepts should be more widely adopted within the review divisions and that staff should find and distribute best practices.