Government
Four bills aimed at lowering prescription drug prices were advanced out of the U.S. Senate Judiciary Committee this week and will head to a vote on the Senate floor.
National Cancer Control Efforts Should Address the System, Not Its Individual Parts, Says New Report
Current cancer control efforts in the United States typically are fragmented and uncoordinated, but taking a systems approach to establish a U.S. National Cancer Control Plan would address the challenge more holistically, says a new report from the National Academies of Sciences, Engineering, and Medicine.
In April, the U.S. Food and Drug Administration (FDA) issued a Refuse to File (RTF) letter to Zogenix for its New Drug Application (NDA) for Fintepla (fenfluramine hydrochloride).
During the first presidential debate of Democratic candidates vying for that party’s presidential nomination, it didn’t take long for the pharma industry to take center stage.
The nation’s drug development efforts have been given additional momentum with the introduction of two new platforms, and a grant scheme for drug discovery and development.
The FDA said the companies marketed the herbal extract with unproven claims. Kratom has not been approved by the FDA for any use.
The partial clinical hold was lifted after the company revised the study protocol for the trial. The partial clinical hold remains on other multiple myeloma trials involving venetoclax.
Glenmark said it should be able to resolve the FDA’s concerns within six to nine weeks and will work with the regulatory agency toward approval.
The order would compel healthcare providers, such as hospitals, to disclose information about negotiated and discounted costs of care.
The regulatory agency is establishing new standards for the approval of opioid medications.
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