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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
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 the latest effort to clean up India’s troubled clinical trial industry, the government is requiring that clinical investigators video record the informed consent process with each study subject. 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
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. 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
Sponsors of medical device clinical trials should avoid recruiting and putting at risk an unnecessarily large number of patients, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
GlaxoSmithKline’s experimental coronary heart disease drug darapladib failed to reduce heart attacks, strokes and major cardiovascular events in a closely watched Phase III clinical trial, deflating some expectations for GSK’s Phase III pipeline. Read More
The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More
An FDA plan detailing how the agency will develop and implement clinical trial data terminology standards for therapeutic areas (TA), which was released last month, could affect the way drug and biologic applications are reviewed. Read More
A proposal moving through the European Parliament to centralize data protection across member states would grant clinical trial participants the ability to demand that their trial data — including data shared between regulators and other entities — be effectively “erased.” Read More
The FDA is leaning on sponsors to convert from paper to electronic capture of clinical trial source data, saying the change should help eliminate unnecessary duplication of data and transcription errors and promote real-time access to data for review. Read More