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A German government agency says the EU’s plan for implementing a clinical trials database lets drugmakers withhold too much information — including study protocols, methods and trial results — under the exemption for commercial confidentiality. Read More
Australian drugmakers want the government to create fast-track approval pathways for new cancer drugs, as well as parallel review processes that simultaneously assess safety and efficacy and reimbursement eligibility for new drugs. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers, investigators and clinical trials coordinators for conduct and data integrity violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More
AstraZeneca is catching the clinical trial transparency wave, creating a new scientific review board to evaluate requests for the company’s data. Read More
Future models for obtaining informed consent from a patient in secondary data-based studies need to consider what patients really care about, a recent study in PLOS One concludes. Read More
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
The European Medicines Agency is revising the way drugmakers conduct studies for drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More
Some of the European Medicines Agency’s current recommendations on documenting quality standards for investigational medications will soon be out of date, as the Clinical Trials Regulation comes into effect next year. Read More
The European Medicines Agency has issued final guidance on clinical trial design for drugmakers developing targeted products to treat lupus — in an effort to encourage more companies to target the underserved disease. Read More