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The Therapeutic Goods Administration is considering adopting 15 EU guidelines relating to drug development, including guidance on biosimilars, lipid disorder therapies and bacterial infections. Read More
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studies to demonstrate whether their product can inadvertently be transmitted to other patients, the FDA says in new draft guidance.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and pharmacodynamic data to show compatibility in clinical trials, according to U.S. Food and Drug Administration draft guidance on non-brand versions of the complex therapies.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
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
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
Drugmakers conducting animal trials to support the development of biological and chemical weapon countermeasures should control for animal age, health, weight and physical environment when designing study protocols, the FDA says in draft guidance implementing the Animal Efficacy Rule. Read More
A new risk-assessment framework for incorporating biomarkers into all types of clinical trials was prompted in part by the challenges, weaknesses and incongruities in international requirements, a consortium of U.S. and EU experts says. Read More