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- FDA issues final guidance on drug-related mobile applicationsThe FDA has released its final guidance addressing software applications that are used in connection with prescription drugs. The guidance clarifies how the agency will evaluate and regulate apps…
- FDA issues warning letters to Baxter and Olympus over GMP and QSR violationsThe U.S. Food and Drug Administration sent formal warning letters to Baxter International and Olympus Medical Systems. The letters allege that both companies failed to meet required good manufactu…