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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
Over the next five years, the FDA plans to release a host of guidances to implement the standardization of electronic drug applications and other regulatory submissions. Read More
PhRMA is resisting the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More
The European Medicines Agency has postponed indefinitely a controversial transparency initiative that would make publicly available detailed information from clinical study reports contained in new drug applications. Read More
Discussions with Alimera ahead of a January advisory committee meeting led the FDA to conclude that the company’s diabetic macular edema drug would be approvable with labeling changes and additional safety data — foregoing the need for the meeting and additional clinical trials. Read More
Manufacturers of antibacterial soaps and body washes may be mandated by the FDA to submit clinical outcome study data on the safety and efficacy of their products, bringing them in line with the agency’s regulation of other over-the-counter medications. Read More