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The FDA warned Chinese API manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Materials for inadequate quality management and record-keeping. Read More
The FDA has warned that water systems used by manufacturers of non-sterile, water-based drugs are at risk of contamination from Burkholderia cepacia, a pathogen resistant to a wide range of antimicrobials. Read More
The U.S. Supreme Court ruled that patent infringement lawsuits may only be filed where defendant companies are incorporated, and not simply in any location where their products are sold — a decision with serious implications for drugmakers. Read More
Scott Gottlieb, in one of his first official acts as FDA commissioner, established an opioid policy steering committee to review the agency’s drug review policies and explore possible actions to lower abuse. Read More
President Trump’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission of ensuring the safety of drugs, which would cut its federal spending by $854 million, to be replaced with $866 million in industry user fees. Read More