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An institutional review board at one of Chicago’s major hospitals was handed an FDA warning letter for a slew of violations — many cited previously — in a medical device clinical trial. Read More
The Canadian government has released a draft guidance aimed at streamlining the approval process for basic clinical trials using positron-emitting radiopharmaceuticals, or PERs. 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
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
The Clinical Data Interchange Standard Consortium (CDISC) is asking for input on a new data submission standard that could give clinical trial sponsors and reviewers greater flexibility if adopted by the FDA for drug review applications. Read More
The FDA has lifted a partial clinical hold on Cell Therapeutics’ blood cancer drug tosedostat, giving the green light for continuing mid-stage clinical trials. Read More
The CMS Tuesday clarified a top concern of drugmakers: which format to use for submitting reports required under the Physician Payment Sunshine Act. Read More
In vitro diagnostics products meant for research or investigational use used commercially without appropriate approvals may be considered adulterated and misbranded, an FDA final guidance says. Read More
In the latest initiative to clean up its troubled clinical trial industry, the Indian government is requiring investigators to video record the informed consent process for each subject in clinical studies. Read More