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The FDA issued guidance on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Read More
Failure to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in new draft guidance. Read More
FDA Commissioner Scott Gottlieb announced a four-pronged agency initiative to take on antimicrobial resistance, in part by creating incentives for drugs that treat it. Read More
FDA Commissioner Scott Gottlieb announced a revised agreement between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too low. Read More
Against a backdrop of declining sales for its branded hepatitis drugs, Gilead announced plans to launch its own “authorized generics” of two of its hep C treatments. Read More
Generic drugmakers are suing New York state over its law imposing surcharges on distributors and manufacturers of opioids, arguing the tax disproportionately hurts generic manufacturers. Read More
The European Medicines Agency (EMA) is considering revisions to its guidance for sponsors of medicines for neonates and is seeking input from stakeholders by Dec. 16. Read More
The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan. Read More
Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far, BMJ reported. Read More
The EMA lowered its estimate for the number of centrally authorized drugs that may face post-Brexit supply disruptions from 108 to 39 — including 25 human medicines. Read More