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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
Advisors to Ministry of Health and Family Welfare are calling for reforms to address weaknesses in India’s clinical investigation and medical products approval processes. Read More
With EU lawmakers and the European Council expected to reach a compromise on clinical trial regulations before Christmas, pharma, researchers and patient groups are asking for assurance that timelines for trial data submissions are predictable and no longer than timelines currently in force. 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
With EU lawmakers and the European Council expected to reach a compromise on the Clinical Trial Regulation before Christmas, pharma, researchers and patient groups are pleading with them to ensure the timelines for submissions are predictable and no longer than those already established in the current directive. Read More
Today’s regulatory culture is too risk-averse when it comes to drug approvals and risks keeping promising treatments off the market, senior officials at the European Medicines Agency say. Read More
In a new “sunshine” bid, Britain’s brand drugmakers will begin disclosing payments made to physicians in connection with the development or sale of medicines, beginning in 2016. Read More
To improve compliance in clinical trials, investigators need to find ways to accommodate individual patient needs and help trial participants understand the rationale behind protocols, an industry report says. Read More
The European Medicines Agency may postpone a trial transparency initiative that was scheduled to take effect Jan. 1, 2014, due to an overwhelming number of comments from stakeholders. Read More
Indian authorities want clinical trial sites accredited and more heavily regulated. In a new report, a panel of advisors to the Ministry of Health and Family Welfare spells out specific reforms aimed at addressing past weaknesses in the country’s clinical investigation and drug approval processes. Read More
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