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Judge Orders FDA, Food Safety Group To Set FSMA Implementation Date

 
• By Chris Walker

FDA’s delays in implementing the Food Safety Modernization Act violated FSMA and the Administrative Procedures Act, a federal court finds in an April 22 order. The agency must meet with plaintiff Center for Food Safety to agree on new implementation deadlines by May 20.

A federal judge ordered FDA to meet with the advocacy group Center For Food Safety to set new deadlines for the agency to implement elements of the Food Safety Modernization Act of 2010.

CFS filed suit Aug. 29, 2012, after FDA failed to enact the new food safety regulations outlined under FSMA within...

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First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide Authority

 
• By Bridget Silverman

As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.