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The FDA would like to know more about whether drug shortages are happening at the point of manufacture or downstream in the supply chain, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni said in remarks yesterday at the FDA/Parenteral Drug Association (PDA) joint regulatory conference. Read More
Novo Nordisk has agreed to a $100 million settlement in a 2017 class action lawsuit that accused the company of making kickbacks to pharmacy benefit managers (PBMs) and failing to disclose information about its revenues related to insulin. Read More
HHS has issued an updated contingency plan in case government funding runs out this week, covering FDA operations in case Congress fails to pass a stopgap measure funding the federal government from Oct. 1 through Dec. 3. Read More
Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), on Friday defended overriding the CDC’s own advisory panel, which voted the previous day not to recommend a Pfizer COVID-19 booster shot for people at high risk of contracting the disease in the workplace. Read More
The FDA continued its implementation of new authorities for certain over-the-counter (OTC) drugs on Friday when it posted a final administrative order for OTC sunscreens. Read More
Two foreign manufactures have been sent FDA warning letters, highlighting sloppy testing of over-the-counter (OTC) analgesics and inadmissible marketing. Read More
The Department of Defense (DoD) is over-reliant on foreign drug supply chains, a problem that could spell big trouble not only for the military, but the entire country, says a new report from the DOD’s Office of the Inspector General (OIG). Read More
A Centers for Disease Control and Prevention (CDC) expert panel yesterday voted 9 to 6 that people aged 18-49 with underlying health conditions should be eligible to receive a booster vaccine, but voted down, 6 to 9, recommending a booster shot for people in that age group at risk of contracting the coronavirus based on their workplace. Read More