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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
Representatives from the FDA and the European Medicines Agency discussed further opportunities for collaboration in their 2018 annual meeting last week. Read More
For the second consecutive week, the House of Representatives passed a slew of bills addressing the opioid crisis, including one on Friday directing the FDA to assess non-addictive treatment options. Read More
The judge rejected claims that FDA regulations preempt state law and that the companies are not accountable for doctor and pharmacist misconduct. Read More
Public Citizen is urging the FDA to take Takeda’s Uloric and all products containing febuxostat off the market after the recent release of a post-market study claiming the gout treatment poses serious risks to patients and offers no unique benefits compared to other lower-risk medications. Read More