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FDA Labeling Change Rule Is Most Prominent Item On Agency’s To-Do List

 
• By Brenda Sandburg

HHS’s semi-annual inventory of rulemaking actions under development includes six prescription drug-related rules.

FDA is working on a half-dozen rules pertaining to prescription drugs, but only one is a new entry on its to-do list: a proposed rule to enable ANDA sponsors to change their product labels without getting prior approval from the agency.

The rule is included in HHS’ semi-annual inventory of rulemaking actions under development, which is slated to be...

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More from North America

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.