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The World Health Organization published its biennial update to its list of essential medicines, adding therapies for hepatitis C, HIV and leukemia, as well as new advice on combating antimicrobial drug resistance. 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
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