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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
PhRMA is resisting the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor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
Sponsors need to report new safety and efficacy findings that emerge during postmarket clinical trials in periodic safety update reports, or PSURs, submitted to the European Medicines Agency. Read More
While MiMedx disagrees with the FDA’s reasoning for requiring BLAs — and, hence, clinical trials — for its regenerative, human cellular and tissue-based products (HCT/Ps), the company says it will oblige the agency to set precedence for future products developed by competitors. Read More
The push for trial data transparency — by regulators and pharma alike — kept sponsors and clinical sites on their toes in 2013. Both sides agreed that more transparency is needed, but they diverged on how to accomplish the goal. India announced new standards for ethics boards and patient compensation, while Japan’s Pharmaceutical and Medical Devices Agency launched an R&D and strategy consulting arm to fine-tune the development of novel products and speed regulatory approvals. Buzz words included “personalized medicine,” “enrichment trials” and “centralized monitoring.” Use this roundup of news highlights in 2013 to plan your clinical trial strategy for the year ahead.Read More
Lawmakers were closer to eliminating the 28 national clinical trial directives and establishing a single authorization procedure for all EU trials, following approval of draft language in December. Parliament is expected to take up the proposed clinical trial regulation during its March plenary session. Read More