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- FDA issues warning letters to drugmakers in China, India and the US over GMP violationsThe U.S. Food and Drug Administration has issued warning letters to a number of manufacturers in China, India and the United States. The letters cite multiple violations of good manufacturing prac…
- Amgen and academic centers discuss FDA pilot to accelerate first-in-human trialsThe U.S. Food and Drug Administration is working with industry and research institutions on a pilot program aimed at speeding first-in-human studies. The effort is intended to counter the rapid tim…