A German regulator says European Medicines Agency plans for implementing its clinical trials database lets drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercial confidentiality. Read More

The UK BioIndustry Association and EuropaBio are calling for European regulators to drop plans to Phase I clinical trial reports, saying the information they contain is commercially sensitive. Read More

Clinical investigators in India could face up to five years in jail for studies that violate the country’s clinical trial regulations, under draft legislation released in late December by the Department of Health and Family Welfare. The prospect could further hinder India’s clinical trials industry, one expert says. Read More

The House Energy & Commerce Committee that oversees the FDA is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing. Read More

Regulators, sponsors and clinical investigators wrestled with trial data transparency and reporting requirements for the second year in a row, with the European Medicines Agency trying to pin down the most effective ways to require sponsors to share the results of their studies. U.S. officials were primarily concerned with stimulating development of new antibiotics, encouraging sponsors and investigators to more deeply analyze subgroup outcomes and promoting the use of biomarkers in drug trials. Read More

Investigators conducting clinical trials in India could for the first time face up to five years in jail for trial violations if lawmakers approve a proposed bill, a possibility that could further hinder the country’s clinical trials industry, one expert says. Read More

The EU ombudsman is questioning the European Medicines Agency’s claim that it wasn’t violating any laws when it allowed AbbVie to redact information from clinical study reports. Read More

As part of an initiative to increase clinical trial transparency, the FDA has launched a website that provides information about the sex, age, race and ethnicity of participants in studies that support drug approvals. Read More

Device and diagnostics makers would have to submit all clinical trial data to the federal government — including data for products never approved by the FDA — under a massive, proposed expansion of data collection. Read More

Drug and biologic makers would have to submit all clinical trial data to the federal government — including data for products not approved by the FDA — under a massive proposed expansion of data collection. Read More

European regulators yesterday told the European Union ombudsman that they adhered to the law when allowing manufacturer AbbVie to redact information from its clinical study reports, marking the latest twist in the debate over European trial data transparency. Read More