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Scientific Integrity Policy Updates At FDA, CDC Due For Completion In July

 
• By Cathy Kelly

HHS-wide update will address agency integrity improvements in the wake of concerns that political considerations inappropriately influenced regulatory decisions related to COVID-19 during the Trump Administration, the General Accountability Office notes in a new report.

Efforts By Congress, Executive Branch Aim To Bolster Public Trust In Health Agencies • Source: Alamy

A US Health and Human Services Department working group with representatives from the US Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institutes of Health expects to formulate an update of the department’s scientific integrity policies for submission to the White House Office of Science and Technology Policy by July.

The initiative responds to a January 2021 White House memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking that directed an interagency task force to develop a...

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Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
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US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
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FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.

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EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
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Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.