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Hebei Yuxing Bio-Engineering, a Chinese producer of active pharmaceutical ingredients, received a warning letter from the FDA citing significant cGMP and data integrity issues discovered at its manufacturing plant. Read More
Option Care Enterprises received a warning letter from the FDA due to deficiencies in the production of sterile drugs and infusion products at its facility in Everett, Wash. Read More
Several senators expressed doubts that the FDA should take on the regulation of tens of thousands of laboratory-developed tests currently being used across the country, during a committee hearing on the future of regulation in an age of precision medicine. Read More
A federal judge signed off on a $486 million settlement between Pfizer and the company’s shareholders to end a long-standing class action suit alleging the company misrepresented the cardiovascular risks of its analgesics Celebrex and Bextra. Read More
The FDA hopes to refine the review process and fee structure for biosimilar products in the next iteration of the Biosimilar User Fee Act to improve efficiency and resource availability. Read More
The FDA should promote greater patient involvement in development of drugs and other treatments for diseases, the National Health Council said in a set of priority considerations for the next presidential administration. Read More
The European Medicines Agency has recommended that three medicines manufactured by Pharmaceuticals International no longer be available in the EU due to possible cross-contamination. Read More