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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.

Vaccine News

Poll: Adults Less Likely To Vaccinate Themselves Than Their Children

The majority of voters favorably view vaccines approved by FDA and are optimistic about the role of future vaccines in preventing health problems, according to a poll conducted earlier this year and released by the Partnership to Fight Infectious Disease (PFID).

Experts Debate Vaccine Prioritization For Pandemic Threats, Neglected Diseases

ASPR Has A ‘Head Start’ On Avian Flu Vaccines, O’Connell Says

Latest News

As FDA Warns Of Compounded Ketamine, Pharmacists Offer Guide

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.

E&C Explores Strategies To Curb Improper Medicare And Medicaid Payments

Congress and CMS could tackle the billions of dollars in improper payments in Medicare and Medicaid by improving data sharing between states and the agency, leveraging artificial intelligence (AI) to enhance data collection and analytics -- an idea that HHS’ OIG is now piloting -- and strengthening oversight, including by encouraging more state audits of Medicaid managed care plans, key federal officials told the House Energy & Commerce subcommittee on oversight and investigations during a Tuesday (April 16) hearing on improper payments.

Colorado Pharmacies Concerned Over PDAB UPL Reimbursements

Colorado pharmacies are concerned they may not receive adequate reimbursement after the state’s prescription drug affordability board (PDAB) determines an upper payment limit (UPL) for drugs it deems unaffordable, and a pharmacy group says it has unanswered questions about the process.