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Drugmakers may use pharmacokinetic bioequivalence studies to compare how two orally-inhaled drugs with the same active substance disperse in the lungs, the European Medicines Agency says. Read More
The UK BioIndustry Association and EuropaBio are calling for European regulators to drop plans to release Phase I clinical trial reports, saying the information they contain is commercially sensitive. Read More
Brazilian regulator Anvisa has set a 90-day timeline for reviewing requests to conduct clinical trials that are also being done in other countries. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued this week. 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 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