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The U.S. District Court for the Eastern District of Tennessee entered a permanent injunction against Crown Laboratories of Johnson City and its CEO, Jeffrey Bedard, after accusations of distributing unapproved and misbranded drugs. The company’s products, which include urea creams and lotions intended to treat dermatological problems, were sold and distributed without FDA approval or a sufficient demonstration of their safety and efficacy, according to the complaint the Justice Department filed in March at the request of the FDA. Read More
Pharmaceutical and medical device companies will not get tax breaks after the Republican effort to repeal the Affordable Care Act came to a halt in the Senate early Friday morning, with nays from Sens. Lisa Murkowski (R-Alaska), Susan Collins (R-Maine) and John McCain (R-Ariz.). Read More
The FDA established a public docket so companies can nominate drug products or categories for the agency’s Difficult to Compound List — which blocks pharmacies from compounding certain products unless they are listed as a manufacturer. Read More
Sen. Claire McCaskill (D-Mo.) expanded her congressional investigation into opioid manufacturers and distributors, sending document requests to an additional four drugmakers. Read More
FDA Commissioner Scott Gottlieb updated lawmakers Thursday on the agency’s plan to help lower drug prices using its “untapped authority” to increase competition and streamline generic drug approvals. Read More
A joint FDA advisory committee voted against recommending approval of Intellipharmaceutics’ extended-release opioid painkiller Rexista, as well as against the claim that it deters abuse. Read More
FDA Commissioner Scott Gottlieb sought to assure agency staff this week that Congress will reauthorize its user fee programs before the Sept. 30 deadline, which promise to provide the agency more than $1.4 billion in funding for reviewing activities and staff salaries in the next fiscal year. Read More