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India’s Central Drugs Standard Control Organization has unveiled three new guidelines that it says paves the way forward for more clinical trials in the country. Read More
The pharmaceutical industry is becoming more active in sharing clinical trial data in a way that may have seemed inconceivable 20 years ago, drugmakers said, even as it has taken heat for being opaque on disclosures. Read More
The European Medicines Agency is moving to reject substitute proof-of-concept trials in place of GCP noncompliant studies during marketing application reviews. Read More
As the pharmaceutical industry makes its way into the digital age, a new initiative launched at UC San Diego hopes to guide ethics standards on the use of personal health data in clinical trials. Read More
Underscoring the importance of pediatric trial design, cancer experts recently guided drugmakers on whether their research plans for two investigational drugs could be feasibly used to combat some of the most life-threatening and hard-to-treat childhood cancers. Read More
The Secretary’s Advisory Committee on Human Research Protections is asking for more data on potential workflow effects of proposed changes to the Common Rule that would require the use of one single IRB across a multi-site trial. Read More
A new cost-benefit study found electronic health records curbed sponsor time and expenses, underscoring the potential that the technology could have for drug development efficiency. Read More
The FDA is now recommending a traditional approval pathway for development of antiretroviral drugs for HIV-1 infection, a major shift from the condensed process allowed since the epidemic was at its peak. Read More