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Some applicants surveyed said they were uncertain about the PRIME designation’s value, and felt it might limit their flexibility with other European regulators. Read More
The agency plans to use the pilot to assess industry’s ability to meet the DSCSA’s requirements, including identifying illegitimate products and preventing diversion. Read More
The agency will use marketing materials about a fictional weight loss drugs and migraine medications to see who reads and retains risk information better. Read More