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- FDA releases draft guidance on potency testing for immunotherapy productsThe FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…
- 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…