We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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
Regulatory affairs folks had little time to relax in 2013, with heated debates over the future of EU device regulations, new controls in Japan and a proposed regulatory framework in India. And that’s just the tip of things. During the year, Malaysia got busy implementing its new device law and Brazil eased the process for device registration. Members of the International Medical Device Regulators Forum cemented plans for a January launch of a single-audit pilot program, and the U.S. Food and Drug Administration finalized rules for unique device identification. Use this review to reflect on developments in 2013 and prepare a winning business strategy in 2014.Read More
PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor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
PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor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
To correct one of the most common problems that sidetracks ANDA submissions, the FDA recommends bioequivalence studies for most drugs submitted as ANDAs should use a two-period, two-sequence, single-dose, crossover study design. Read More
Beginning today, new safety and efficacy findings that emerge during postmarket clinical trials should be reported in periodic safety update reports (PSURs) submitted to the European Medicines Agency (EMA). Read More
Clinical investigators in India must begin video recording the informed consent process for each study subject, the latest step in the government’s initiative to clean up the country’s troubled clinical trial industry. Read More
An agreement is expected to be reached on the Clinical Trial Regulation between EU lawmakers and the European Council by Christmas, and industry groups are asking to ensure the timelines for submissions are predictable and no longer than those already established in the current directive. Read More