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The French government broadened its legal definition of biomedical research to all research involving humans, including observational studies. Read More
As of the end of fiscal 2015, postmarket requirements were fulfilled for 69 percent of NDAs, marking a slight decline from the previous fiscal year. Read More
The International Council for Harmonisation adopted an update to its good clinical practice guideline, recommending approaches to clinical trial design and management, as well as ensuring patient protection and data integrity. The amendment to its E6 guideline will now be implemented by ICH members through national and regional guidance. Read More
The FDA is now directing sponsors to international guideline recommendations for the durations of general toxicity studies that evaluate the direct dosing of drug metabolites. Read More
Pharmaceutical companies completing research in pediatric populations said that the studies required have become more complex and more expensive since 2008. Read More
The future of drug development and regulatory approvals must include the use of real world evidence, according to FDA Commissioner Robert Califf. Read More
The lowest-cost patient-centered initiatives — such as involving advisory groups and offering patient counseling and education — led to the largest returns in clinical trial performance. Read More
The European Medicines Agency broadened the scope of its first-in-human trials guidelines, accounting for advancements in clinical trials protocols and complex dose-escalation studies. Read More
The FDA published recommendations for clinical trial designs for patients with bladder cancer, with separate considerations for patients with and without active disease. The agency’s draft guidance focuses on developing drugs and biologics for non-muscle invasive disease that has not responded to treatment with bacillus Calmette-Guerin immunotherapy. Read More
The development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Read More
The FTC is urging a D.C. federal court not to postpone an order that requires Boehringer Ingelheim to hand over documents in a pay-for-delay lawsuit involving the blood thinner, Aggrenox. Read More