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An FDA investigation into serious quality problems at a Florida pharmaceutical company revealed a litany of unsound practices in the manufacture of experimental drugs. Read More
The FDA hit multiple manufacturers with extensive Form 483s, including an Ohio outsourcing facility where failures to adhere to GMP and overall sterility, cleaning and quality control issues proved to be problems repeated from an inspection a year before. Read More
The European Medicines Agency answered the most pressing questions related to the United Kingdom’s exit from the European Union, making it clear UK-made products would be subject to import quality inspections — and that companies in the UK may have to relocate their pharmacovigilance work and personnel to comply with regulations. Read More
Significant GMP violations and repeating problems at U.S. companies across the drug supply chain lead the FDA to issue warning letters, including a lack of product testing at an Oklahoma drug manufacturer. Read More
What’s the best way to get ready for an FDA GMP inspection? Practice, says international quality expert Thomas Peither. Self-inspection or a fresh set of eyes in the form of an external consultant play an important role in audit preparation. Read More
The FDA warned Chinese API manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Materials for inadequate quality management and record-keeping. Read More
FDA Commissioner Scott Gottlieb spent the early weeks of his tenure in the agency’s top job laying out his priorities before senior FDA staff and members of Congress and announcing the agency’s hiring freeze had officially been lifted. Read More
President Trump’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission of ensuring the safety and quality of drugs, which would cut federal spending by $854 million, to be replaced with $866 million in industry user fees. Read More
FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure in mid-May, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers and ultimately moving to what may seem like stricter inspections, especially at first. Read More