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For Combination Product Development, Industry Says Talk Is Cheap

 
• By Derrick Gingery

Industry official says FDA is responsive to questions from sponsors, but should issue more written guidance to help sponsors make development decisions.

FDA may encourage direct talks with sponsors to answer questions about combination product development, but at some point the agency has to issue more paper outlining its regulatory practices, an industry official said.

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More from United States

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
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US FDA Staff’s Union President Calls For More Support From Industry

 
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Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.

New US FDA Roadmap Moves Closer To Animal Testing Alternatives

 
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New plan to encourage alternatives to animal testing seeks interagency cooperation to meet more aggressive targets for transformational change than the US FDA’s long-standing program.

HHS’ Kennedy Warns US FDA Staff Against ‘Agency Capture’ By Industry, Special Interests

 
• By Sue Sutter

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.

More from North America

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

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

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.

Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say

 
• By Sarah Karlin-Smith

The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.