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Trump Slams FDA Regulations In Joint Session Of Congress

 
• By Michael Cipriano

US president hit on his sentiments of faster drug approval times and deregulation, signaling FDA could be in for period of sustained criticism.

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President Trump offered an uplifting story about drug approvals during his Feb. 28 address at a joint session of Congress, but unfortunately for FDA, it was the villain in the piece, with "burdensome" agency restrictions becoming a key example in Trump’s criticism of government over-regulation.

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• By Neena Brizmohun

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• By Sue Sutter

Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."

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Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

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US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.