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CDER Director Cavazzoni Highlights Center’s Modernization Work

FDA’s drug center is striving to keep up with innovation in medical technology and an increased amount of data to analyze around regulatory decisions for drugs, according to its director, who promotes initiatives that ramp up a focus on quantitative data analysis, encourage innovative clinical trial approaches and make sure its advisory committees are fit for purpose.

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Burgess: Site Neutral Policies Key To Stable Doc Pay, Lower Overall Costs

Implementing site-neutral Medicare payment policies could replace the budget neutrality requirements that have driven cuts to physician pay while supporting independent practices and lowering overall health care costs for the American people,

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The top Republican on the Senate health committee is criticizing FDA’s approach to regulating clinical decision support (CDS) software, asking the agency for more information about how it crafted its guidance on the technology and whether it has documentation of threats posed to patients.

State insurance regulators have established a multi-state steering group that will look at how February’s cyberattack on Change Healthcare unfolded, assess how insurance carriers and other impacted entities reacted, and facilitate discussions about the response and recovery efforts with UnitedHealth Group and Change Healthcare, as well as ensure the country is better prepared for the next, inevitable attack.

Sen. Bill Cassidy (R-LA), the ranking member of the Senate health committee, is requesting regular briefings from the Biden administration on the outbreak of avian influenza (H5N1) among livestock and wild animals in the United States, saying federal agencies must increase their transparency around interagency response to the outbreak.

The Alliance for Pharmacy Compounding (APC) released a best practice guide for compounding pharmacies that offers recommendations on the preparation of ketamine drugs while the advocates criticize FDA for warning consumers about safety risks of compounded ketamine therapies without taking actions to make the treatments safe.