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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 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 European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows. Read More
Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More
The FDA has given its blessing to Wellstat Therapeutics’ Vistogard for the emergency treatment of adults and children who receive an overdose of chemotherapy treatment fluorouracil or capecitabine. Read More