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…
Sen. Claire McCaskill (D-Mo.) expanded her congressional investigation into opioid manufacturers and distributors, sending document requests to an additional four drugmakers. Source: Drug Industry Daily
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. Source: Drug…
Sterility concerns and other deficiencies at a Maryland drugmaker could be putting patients at risk, the FDA told Option Care Enterprises in Columbia, Md. in a July 20 warning letter.…
A Pennsylvania federal court ruled that 11 generic manufacturers, including several subsidiaries of Teva Pharmaceuticals, must answer to a class-action lawsuit claiming they violated state consumer protection and unfair trade…
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. Source: Drug Industry Daily
Celgene reached a civil settlement with the Department of Justice and 28 states, as well as Washington D.C. and the city of Chicago, agreeing to pay $280 million to resolve…
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…
The European Medicines Agency revised its guideline on first-in-human clinical trials, highlighting the sponsor’s responsibility for mitigating risks to volunteers.in the study design. Source: Drug Industry Daily
Missouri Gov. Eric Greitens (R) directed his health department to begin building a state prescription drug monitoring program to track prescribing and dispensing of several controlled drugs, including opioids. Source:…