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A coalition of healthcare and patient advocacy groups Tuesday urged congressional leaders not to reduce the manufacturer discount for Medicare Part D drugs. Read More
The FDA Tuesday issued draft guidance for clinical trial sponsors of treatments for a rare form of prostate cancer — nonmestastatic, castration-resistant prostate cancer (nmCRPC) — and said it will consider metastasis-free survival as an endpoint. Read More
Researchers in low-risk clinical trials could experiment on patients without obtaining informed consent if they meet at least four conditions, the FDA proposed Tuesday in a new rulemaking notice. Read More
Some nations may be consuming too many antibiotics that the World Health Organization has determined must be reserved for emergencies to limit antibiotic resistance. Read More
The FDA hit back at Teva’s lawsuit accusing the agency of changing its policy on granting 180-day exclusivity for generics — arguing that the company’s attempt to block exclusivity for competing Restasis (cyclosporine) generics was “built atop a tottering tower of conjecture.” Read More
The agency said its website has seen a steady increase in traffic over the last three years compared to relatively stagnant activity on mobile devices. Read More