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A federal court panel ruled that the Philadelphia law firm Sheller PC cannot challenge the FDA’s denial of a citizen petition, saying the firm lacks standing based on its failure to show a causal relationship between the agency’s actions and its financial burdens. Read More
Mylan will pay $465 million to settle claims that the company misclassified its epinephrine auto-injector EpiPen for the Medicaid Drug Rebate program, allowing it to pay lower reimbursement rate to states for almost a decade. Read More
An FDA inspection found microbiological contamination of drugs purporting to be sterile at a Bausch & Lomb manufacturing facility in Florida, according to a Form 483 handed to the company. Read More
The European Medicines Agency has recommended that three medicines manufactured by Pharmaceuticals International Inc. (PII) no longer be available in the EU due to possible cross-contamination. Read More
A year from now, each drug product processed and moved through the U.S. supply chain could have its own unique identifier under the Drug Supply Security Act, FDA and industry officials said at a meeting Monday. Read More
The FDA encouraged additional development in topical treatments for head lice infestation, especially in pediatric populations, due to the genetic resistance to the most common treatments. Read More
The DEA has reduced the amount of Schedule II opiate and opioid medications that can be manufactured in the U.S. next year by at least 25 percent. Read More
A European Parliament committee is proposing that the European Commission promote transparency in private research to foster better access to medicines across the EU. Read More
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