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In observance of Martin Luther King Jr. Day, Drug Industry Daily will not be published Monday, Jan. 20. The next issue will be published Tuesday, Jan. 21. Read More
The FDA released a draft guidance for oncology drug developers on submitting initial pediatric study plans (iPSPs) after new requirements go into effect on August 18. Read More
Rochester Drug Co-operative, one of the country’s top ten drug distributors, is pulling the plug on its opioid distribution operations after running into serious legal and regulatory troubles. Read More
It may be time to simplify the FDA’s many expedited review programs, according to a Harvard research team that studied the agency’s drug reviews over the past four decades. Read More