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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Agency’s current recommendations on documenting quality standards for investigational medications will soon be out of date, as the Clinical Trials Regulation comes into effect next year.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
The FDA is giving industry and other interested parties another 30 days to weigh in on its request for suggestions on new biomarkers to speed drug development, according to an FDA notice. Read More
The FDA has laid out the procedures drugmakers should follow in preparing for critical path innovation meetings designed to bring drugmakers, patient groups and regulators together to decide how to use experimental and untested methodologies that can advance drug development. Read More
The FDA should make unredacted results of clinical trial site inspections more readily available to the public and to readers and editors of scientific journals, to ensure transparency about tainted studies and potentially bogus drugs, an article in the February JAMA Internal Medicine says. Read More
The FDA needs to work with devicemakers and Congress to understand why clinical development takes longer here than in other countries and then implement changes to speed up the process, a new study concludes. Read More
The UK BioIndustry Association and EuropaBio are calling on European regulators to defer plans to report Phase I clinical trial reports, saying the information they contain is commercially sensitive. Read More
Biopharmaceutical companies can now pool and search clinical investigators’ information in a central, cloud-based database, thanks to an expanded investigator registry being developed by TransCelerate BioPharma and DrugDev. Read More
The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them to a researcher, setting up a test case for the EU’s new trial transparency policy. Read More
The Office of Human Research Protections’ recent proposal to classify risk-comparison trials as “greater than minimal risk” will force physicians and patients to engage in overly burdensome informed consent processes that are out of proportion to the scope of the trials themselves, a leading bioethicist says. Read More
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued March 3 by the Central Drugs Standard Control Organization. Read More