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Drugmakers that promote their products in real time on blogs, social media sites and other interactive websites need to submit those sites to the FDA for review as promotions. Read More
The Justice Department recovered about $1.2 billion in drug-related False Claims Act (FCA) settlements and judgments in fiscal 2013, a drop from last year’s total. Read More
When creating product labels for the Canadian market, drugmakers’ claims should be based on the product’s own merits rather than on how it compares to other products, Health Canada says. Read More
Rachel Sherman, CDER’s associate director for medical policy and director of the Office of Medical Policy (OMP), will retire Jan. 25 after serving 25 years at the FDA. Read More
Because nanosized solubilizers known as block copolymer micelles (BCM) contain highly functional polymers, drugmakers that use them are recommended to apply quality-by-design (QbD) principles within a “well-defined manufacturing process” to ensure consistent quality. Read More
Congressional lawmakers will work to eliminate the Physician Payment Sunshine Act requirement that drugmakers disclose gifts of medical journals and textbooks to physicians after the Centers for Medicare & Medicaid Services (CMS) refused their request to reverse the policy. Read More
Japanese authorities Friday launched an investigation into claims that falsified clinical trial data was used in an Alzheimer’s study involving several major drugmakers, marking an expansion of the country’s scrutiny of trial data misuse. Read More
Lawmakers and the White House Office of Management and Budget (OMB) have agreed on language to include in an omnibus fiscal 2014 appropriations bill that will allow the FDA to retrieve $85 million in user fees sequestered last year. Congress had set a deadline of Jan. 15 for voting on the bill; however, lawmakers signaled Friday they may need more time for debate. Read More
Government prosecutors are asking Aegerion Pharmaceuticals to hand over documents tied to sales and marketing of its cholesterol drug Juxtapid, putting the company in the spotlight for compliance concerns for a second time. Read More
Santaris Pharma and GlaxoSmithKline have signed a deal giving GSK access to Santaris’ locked nucleic acid technology in order to develop RNA-targeted medicines. Read More