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The FDA doesn’t have explicit penalties for failing to self-identify as a generic facility, but noncompliance can raise the likelihood of a pre-approval inspection, the agency. Read More
The FDA will revise its recommendations for the submission of quality metrics and provide advice on comparative analyses for drug-device generics before the year ends. Read More
The U.S. Department of Justice issued grand jury subpoenas to Taro Pharmaceuticals and two of the company’s senior officials over the pricing of its generics, the drugmaker revealed in an SEC filing. Read More
The FDA expects to refine the review process and fee structure for biosimilar products in the next iteration of the Biosimilar User Fee Act to improve efficiency and resource availability. Read More
The European Directorate for the Quality of Medicines and a number of foreign pharmaceutical authorities have agreed to improve information-sharing efforts and to strengthen collaboration. Read More
The FDA is revising the list of drug products that have been banned or removed from the market for safety or effectiveness reasons and so cannot be used in compounding. Read More
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