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The FDA’s proposed plan for spending the $500 million allocated by the 21st Century Cures Act through fiscal 2025 prioritizes patient-focused drug development, qualification of biomarkers, and the use of real-world evidence. Read More
The FDA issued a Form 483 to drug manufacturer Amerigen for insufficient record-keeping and quality controls following a November 2016 inspection of the company’s Suzhou, China, facility. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including ensuring GMP compliance and quality throughout supply chains. Read More
The European Medicines Agency is planning to revise its guideline on the role of pharmacokinetics in pediatric drug development and is inviting public comment. Read More
The Senate on Thursday approved the House version of a spending bill for fiscal 2017 in a 79-18 vote — including a modest increase in FDA funds through September. The president was expected to sign the bill into law quickly. Read More