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In a retrial, a jury ordered AbbVie to pay more than $3 million to a plaintiff who blamed his heart attack on misrepresentation of the risks posed by AbbVie’s testosterone replacement drug AndroGel. Read More
Senate Health Committee Chairman Lamar Alexander (R-Tenn.) released two draft bills that would provide the FDA with more tools to deal with the opioid crisis. Read More
Sanofi called for removing the requirement for a reference list of SOPs from the requirements for CMC supplements, noting that SOPs are already reviewed as part of GMP inspections. Read More
A Delaware federal judge found generic drug developer Alvogen did not infringe on three Invidior patents for the opioid addiction drug Suboxone, specifically relating to the process for drying Suboxone’s sublingual film. Read More
The FDA should avoid duplicating existing requirements in its updated guidance on chemistry, manufacturing and controls information for biologics, according to PhRMA and several drugmakers in comments to the agency. Read More
The FDA issued guidance for sponsors developing chronic obstructive pulmonary disease (COPD) treatments, clarifying how to efficiently use the St. George’s Respiratory Questionnaire a patient-reported outcome measure assessment tool. Read More
The FDA last week previewed an upcoming pilot project that offers initial reviews of protocols for clinical trials with highly complex, innovative designs. Read More