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FDA Commissioner Scott Gottlieb said the approval “serves as a reminder that advancing sound development programs that properly evaluate active ingredients… Read More
The Federal Trade Commission should examine the impact of “pay-for-delay” deals on the availability of cheaper biosimilars, two U.S. senators said in a letter Friday. Read More
Two pharmacy benefit managers took in more than $223 million last year through their work with Ohio Medicaid plans, according to a new report commissioned by the state. Read More
In the coming weeks, CDER will publish online a list of surrogate endpoints that led to the approval of oncology drugs and biologicals for the first time, FDA Commissioner Scott Gottlieb announced at the National Comprehensive Cancer Network Policy Summit in Washington, D.C. Read More
During the meeting, the agencies committed to including vaccines and plasma-derived drugs in the scope of the agreement no later than July 2022. Read More
Serenity, meanwhile, petitioned the FDA to deny the application because Ferring had not demonstrated the drug is safe or clinically beneficial for use in patients with nocturia and said the company’s study design was insufficient to accurately assess the safety risks. Read More
Questions asked during INTERACT meetings should focus on topics related or similar to preclinical testing requirements, aspects of manufacturing required for first-in-human trials, device or assay design considerations and initial clinical development strategies. Read More
The agency is implementing on a 2017 commitment from Canada’s Minister of Health to ensure opioid prescriptions are properly tracked and increase the transparency of opioid marketing. Read More
In an effort to provide potential sponsors advice on critical topics for early drug development, CBER launched its Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meetings program. Read More
The FDA approved Ferring Pharmaceuticals’ NDA for Nocdurna (desmopressin), a nocturia treatment, rejecting petitions from Serenity Pharmaceuticals and Avadel requesting that it deny the application. Read More