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As one of its last items of business before leaving town for the summer, the Senate overwhelmingly voted to reauthorize the FDA’s user fee agreements through fiscal 2022, completing over two years of work and negotiations with private industry. Read More
They include revisions to GMPs for raw ingredients and finished products, changes in annual IND reporting, and requirements for new, clearer labeling for patients in medication guides. Read More
A California company violated federal law by making and selling as a dietary supplement a product containing prescription drugs used to treat erectile dysfunction, the FDA said. Read More
The European Medicines Agency developed a continuity plan to handle the workload linked to the UK’s withdrawal from the European Union and the relocation of the EMA’s headquarters. Read More
Drug companies must ensure their products meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2. Read More