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Patient recruitment remains one of the biggest roadblocks to speedy clinical trials, but the problem could be eased with greater use of electronic health records, a panel of experts told lawmakers Wednesday. Read More
Investigators participating in clinical trials in India must limit their work to no more than three trials at any given time. That’s one of mandates laid out in 14 finalized regulations issued July 3 by the Central Drugs Standard Control Organization. Read More
Biologics makers planning new genetically engineered drugs derived from viruses and bacteria need to conduct studies to demonstrate whether their product can inadvertently be transmitted to other patients, the FDA says in new draft guidance. Read More
The FDA is reaching out to sponsors of trials of therapies for neglected tropical diseases with new final guidance that encourages them to seek accelerated approval pathways, such as breakthrough therapy designation and qualified infectious disease product status. Read More
Sponsors conducting clinical trials of therapies for chronic kidney disease should design comparator trials when an approved therapy exists for the same indication, the European Medicines Agency said Tuesday. Read More
Sponsors of biosimilars need to demonstrate how their products compare with reference drugs, including pharmacokinetic and pharmacodynamic data to show compatibility in clinical trials, according to U.S. Food and Drug Administration draft guidance on non-brand versions of the complex therapies. Read More
Clinical investigators looking to develop new therapies for children with Gaucher disease may use either multi-company, multi-arm trials or data extrapolation techniques, according to a joint strategic plan released by the U.S. Food and Drug Administration and European Medicines Agency. Read More
The European Medicines Agency is pushing back against critics who accuse it of softening its commitment to clinical trials data transparency, saying there has been “absolutely no change in direction” in the agency’s efforts to make trial data more publicly available. Read More
Drug companies that redact commercially confidential information from clinical study reports in Europe will have to justify their actions, a spokesman for the European Medicines Agency says. Read More
Failure to include women in device trials may be blocking important discoveries in new treatment modalities, CDRH says in commentary on a study published in JAMA: Internal Medicine. Read More
A trade group of leading Indian drug companies is pushing the government to settle a prolonged lawsuit over clinical trial deaths; a move that two industry consulting groups are hopeful will revive sluggish clinical trial activity in the country. Read More
Clinical investigators looking to develop new therapies for children with Gaucher disease may use multi-company, multi-arm trials or data extrapolation techniques, according to a joint strategic plan released by the FDA and European Medicines Agency. Read More