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CDER Director Janet Woodcock is calling on industry to collaborate in the development and verification of new biomarkers, which the agency says can improve clinical trial efficiency but so far have been underused. Read More
Clinical trial investigators in India must limit their work to no more than three trials at any given time, according to one of the mandates in 14 finalized regulations issued by the Central Drugs Standard Control Organization. Read More
A public-private partnership in the EU plans to spend $4.5 billion over the next decade to boost, by 30 percent, the success of clinical trials on high-priority drugs. Read More
Clinical trial investigators in India must limit their work to no more than three trials at any given time, according to one of the mandates in 14 finalized regulations issued by the Central Drugs Standard Control Organization.
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Sponsors of device clinical trials should carefully examine the demographic distribution of study participants at various points during the study, the FDA says in final guidance published Wednesday. Read More
Implantable heart devices improve the chances of survival across racial groups, a study published in Tuesday’s Journal of the American College of Cardiologists concludes. Read More
The FDA has released a three-point action plan aimed at encouraging more diverse patient participation in medical device and drug clinical trials. Read More
The Department of Justice has closed its civil investigation into alleged data falsification in a clinical trial for AstraZeneca’s heart drug Brilinta, a move that clears the way for the drug to potentially reach blockbuster status. Read More
The FDA is asking Acura Pharmaceuticals to conduct an additional study to prove its abuse-deterrent painkiller can actually deter abuse, throwing a wrench into the small drugmaker’s plans for approval. Read More
Rigel Pharmaceuticals said Wednesday it will not initiate any new studies of R348 for the treatment of dry eye disease, after the compound failed to meet its primary and secondary endpoints in a recently completed Phase II trial. Read More
Clinical sites facing an inspection at the request of the Committee for Medicinal Products for Human Use must sign a letter consenting to the audit and promising to provide all relevant documents, a European Medicines Agency guideline on GCP inspection procedures says. Read More
Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22. Read More