The QMN Weekly Bulletin

Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline.

Drugmakers and regulators can be more confident about the rigor of trial data coming from emerging markets as the quality of studies appears to be on par with trials in more research savvy, developed nations, a new study concludes.

As House and Senate leaders agreed on a final Prescription Drug User Fee Act (PDUFA) reauthorization package, members of Congress provided the agency with most of the increased supply chain oversight powers it asked for.

The FDA has warned the IRB at a large Illinois healthcare system for enrolling emergency room patients in a clinical trial without their permission.

Countries in the Association of Southeast Asian Nations (ASEAN) would have to establish postmarketing surveillance alert systems to report and evaluate device-related adverse events and make the information available to other member states under a draft medical device directive released for comment this summer.

Los Angeles weight-loss surgery clinic Lap-Band VIP has received an FDA warning letter for misleading marketing claims.

Amid lingering quality issues at a number of its manufacturing plants, Hospira reported some success in its discussions with the FDA but notes there are more trouble spots than the company previously thought.

The FDA is giving manufacturers of prescription anti-spasmodic, gastrointestinal and hypertension medications that were cited as unapproved drugs decades ago until Aug. 23 to inform the agency if they still want to appeal its decision on the need for an NDA.