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The European Medicines Agency is taking a hard look at whether patients taking inhaled corticosteroids for chronic obstructive pulmonary disease are at higher risk for pneumonia. Read More
The European Medicines Agency is tightening its rules around conflicts of interest, barring individuals who take jobs in industry from serving on any of its advisory committees. Read More
Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, regulators say. Read More
Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows. Read More
The U.S. Food and Drug Administration increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds. Read More
The Therapeutic Goods Administration is considering raising the threshold for classifying rare diseases, as well as the number of patients in specific subsets of a disease, to broaden the scope of drugs that qualify for orphan status. Read More
The House Energy & Commerce Committee passed the 21st Century Cures Act on May 21, a measure that would extend the rare pediatric disease priority review voucher program from its current sunset date in March 2016 through December 2018. Read More
A slew of observations related to control records, data integrity and manufacturing at Dr. Reddy’s Andhra Pradesh, India, facility resulted in a Form 483. Read More
The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards. Read More