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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
Baxter is recalling two lots of Clinimix and one lot of Clinimix E premixed sterile parenteral nutrition products over complaints of particulate matter. Read More
China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More
FDA Chief Scientist Jesse Goodman is leaving for Georgetown University and the D.C. Veterans Administration Hospital to serve as a professor and to practice medicine, FDA Commissioner Margaret Hamburg said Thursday. Read More